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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
Phrenic nerve stimulator shows heart failure benefits
DALLAS– Heart failure patients with central sleep apnea who received treatment with a transvenous phrenic nerve–stimulating device showed dramatic improvement in their global self-assessment, compared with control patients, in a subgroup analysis of 80 patients enrolled in the device’s pivotal trial.
Among 35 patients with heart failure enrolled in the remedē System pivotal trial and treated for 6 months with phrenic nerve stimulation, 57% reported that they had “markedly” or “moderately” improved, compared with a 9% rate for this self-rating among 44 control heart failure patients in the trial, a statistically significant difference, Lee R. Goldberg, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Further analysis focused on echocardiographic examinations after 12 months in 23 of the heart failure patients who entered the study with a left ventricular ejection fraction of 45% or less and received 12 months of phrenic nerve stimulation. The average LVEF rose in these patients from 30% at baseline to 35%, a statistically significant difference, and left ventricular end systolic volume fell by an average of almost 11 mL from baseline, a difference just short of statistical significance, findings Dr. Goldberg called “a little exciting.”
“It is very encouraging to see some evidence for ventricular remodeling,” commented Lynne W. Stevenson, MD, professor of medicine and a heart failure specialist at Vanderbilt University in Nashville, Tenn.
The FDA approved the use of this device for the treatment of moderate to severe central sleep apnea on Oct. 6. “I think we would use it” in heart failure patients with intolerable symptoms from central sleep apnea, Dr. Goldberg said in an interview during the meeting.
“There is a tight connection between sleep-disordered breathing, sleep apnea, heart failure, and cardiovascular disease, and we have been pretty aggressive in trying to treat the sleep apnea. Even if phrenic nerve stimulation just improves patients’ quality of life and is neutral for other outcomes,” it would be reasonable to offer it to patients, he said. “But many of us think there is a bigger connection that results in a therapeutic benefit [to heart failure patients] by treating their central sleep apnea.”
The pivotal trial enrolled a total of 151 patients with central sleep apnea at 31 centers in Germany, Poland, and the United States who were selected based on having an apnea-hypopnea index of at least 20 events per hour. All participants received a transvenous phrenic nerve–stimulator implant, and then randomization assigned 73 patients to have the device turned on for the first 6 months while 78 device recipients had their devices left off to serve as controls. The study’s primary efficacy endpoint was the percentage of patients having at least a 50% cut in their apnea-hypopnea index, which happened in 51% of evaluable patients in the active treatment arm and in 11% of the evaluable controls. The primary results were published last year (Lancet. 2016 Sep 3;388[10048]974-82).
“We hope this treatment will have the collateral effect of improving cardiovascular disease outcomes, but we don’t know that yet. The initial target will be patients with apnea-hypopnea episodes that affect their quality of life,” Dr. Goldberg said.
The apparent safety of this approach for treating central sleep apnea may relate to its mechanism of action, he suggested. The mortality-boosting effect of adaptive servo-ventilation may correlate with the positive pressure it creates in a patient’s chest that perhaps causes myocardial stress or hemodynamic problems. In contrast, phrenic nerve stimulation produces diaphragm motion that mimics normal breathing and creates negative chest pressure. “A lot of hypothesis generation needs to happen to better understand the underlying physiology,” Dr. Goldberg conceded.
At the end of the 6-month period that compared active treatment with control, the heart failure subgroup also showed statistically significant benefits from treatment for several sleep metrics, including apnea-hypopnea index, the central apnea index, and oxygen desaturation, and also for daytime sleepiness measured on the Epworth Sleepiness Scale. After 12 months on active treatment, patients also showed a significant improvement over baseline in their score on the Minnesota Living With Heart Failure Questionnaire, Dr. Goldberg reported.
The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
DALLAS– Heart failure patients with central sleep apnea who received treatment with a transvenous phrenic nerve–stimulating device showed dramatic improvement in their global self-assessment, compared with control patients, in a subgroup analysis of 80 patients enrolled in the device’s pivotal trial.
Among 35 patients with heart failure enrolled in the remedē System pivotal trial and treated for 6 months with phrenic nerve stimulation, 57% reported that they had “markedly” or “moderately” improved, compared with a 9% rate for this self-rating among 44 control heart failure patients in the trial, a statistically significant difference, Lee R. Goldberg, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Further analysis focused on echocardiographic examinations after 12 months in 23 of the heart failure patients who entered the study with a left ventricular ejection fraction of 45% or less and received 12 months of phrenic nerve stimulation. The average LVEF rose in these patients from 30% at baseline to 35%, a statistically significant difference, and left ventricular end systolic volume fell by an average of almost 11 mL from baseline, a difference just short of statistical significance, findings Dr. Goldberg called “a little exciting.”
“It is very encouraging to see some evidence for ventricular remodeling,” commented Lynne W. Stevenson, MD, professor of medicine and a heart failure specialist at Vanderbilt University in Nashville, Tenn.
The FDA approved the use of this device for the treatment of moderate to severe central sleep apnea on Oct. 6. “I think we would use it” in heart failure patients with intolerable symptoms from central sleep apnea, Dr. Goldberg said in an interview during the meeting.
“There is a tight connection between sleep-disordered breathing, sleep apnea, heart failure, and cardiovascular disease, and we have been pretty aggressive in trying to treat the sleep apnea. Even if phrenic nerve stimulation just improves patients’ quality of life and is neutral for other outcomes,” it would be reasonable to offer it to patients, he said. “But many of us think there is a bigger connection that results in a therapeutic benefit [to heart failure patients] by treating their central sleep apnea.”
The pivotal trial enrolled a total of 151 patients with central sleep apnea at 31 centers in Germany, Poland, and the United States who were selected based on having an apnea-hypopnea index of at least 20 events per hour. All participants received a transvenous phrenic nerve–stimulator implant, and then randomization assigned 73 patients to have the device turned on for the first 6 months while 78 device recipients had their devices left off to serve as controls. The study’s primary efficacy endpoint was the percentage of patients having at least a 50% cut in their apnea-hypopnea index, which happened in 51% of evaluable patients in the active treatment arm and in 11% of the evaluable controls. The primary results were published last year (Lancet. 2016 Sep 3;388[10048]974-82).
“We hope this treatment will have the collateral effect of improving cardiovascular disease outcomes, but we don’t know that yet. The initial target will be patients with apnea-hypopnea episodes that affect their quality of life,” Dr. Goldberg said.
The apparent safety of this approach for treating central sleep apnea may relate to its mechanism of action, he suggested. The mortality-boosting effect of adaptive servo-ventilation may correlate with the positive pressure it creates in a patient’s chest that perhaps causes myocardial stress or hemodynamic problems. In contrast, phrenic nerve stimulation produces diaphragm motion that mimics normal breathing and creates negative chest pressure. “A lot of hypothesis generation needs to happen to better understand the underlying physiology,” Dr. Goldberg conceded.
At the end of the 6-month period that compared active treatment with control, the heart failure subgroup also showed statistically significant benefits from treatment for several sleep metrics, including apnea-hypopnea index, the central apnea index, and oxygen desaturation, and also for daytime sleepiness measured on the Epworth Sleepiness Scale. After 12 months on active treatment, patients also showed a significant improvement over baseline in their score on the Minnesota Living With Heart Failure Questionnaire, Dr. Goldberg reported.
The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
DALLAS– Heart failure patients with central sleep apnea who received treatment with a transvenous phrenic nerve–stimulating device showed dramatic improvement in their global self-assessment, compared with control patients, in a subgroup analysis of 80 patients enrolled in the device’s pivotal trial.
Among 35 patients with heart failure enrolled in the remedē System pivotal trial and treated for 6 months with phrenic nerve stimulation, 57% reported that they had “markedly” or “moderately” improved, compared with a 9% rate for this self-rating among 44 control heart failure patients in the trial, a statistically significant difference, Lee R. Goldberg, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Further analysis focused on echocardiographic examinations after 12 months in 23 of the heart failure patients who entered the study with a left ventricular ejection fraction of 45% or less and received 12 months of phrenic nerve stimulation. The average LVEF rose in these patients from 30% at baseline to 35%, a statistically significant difference, and left ventricular end systolic volume fell by an average of almost 11 mL from baseline, a difference just short of statistical significance, findings Dr. Goldberg called “a little exciting.”
“It is very encouraging to see some evidence for ventricular remodeling,” commented Lynne W. Stevenson, MD, professor of medicine and a heart failure specialist at Vanderbilt University in Nashville, Tenn.
The FDA approved the use of this device for the treatment of moderate to severe central sleep apnea on Oct. 6. “I think we would use it” in heart failure patients with intolerable symptoms from central sleep apnea, Dr. Goldberg said in an interview during the meeting.
“There is a tight connection between sleep-disordered breathing, sleep apnea, heart failure, and cardiovascular disease, and we have been pretty aggressive in trying to treat the sleep apnea. Even if phrenic nerve stimulation just improves patients’ quality of life and is neutral for other outcomes,” it would be reasonable to offer it to patients, he said. “But many of us think there is a bigger connection that results in a therapeutic benefit [to heart failure patients] by treating their central sleep apnea.”
The pivotal trial enrolled a total of 151 patients with central sleep apnea at 31 centers in Germany, Poland, and the United States who were selected based on having an apnea-hypopnea index of at least 20 events per hour. All participants received a transvenous phrenic nerve–stimulator implant, and then randomization assigned 73 patients to have the device turned on for the first 6 months while 78 device recipients had their devices left off to serve as controls. The study’s primary efficacy endpoint was the percentage of patients having at least a 50% cut in their apnea-hypopnea index, which happened in 51% of evaluable patients in the active treatment arm and in 11% of the evaluable controls. The primary results were published last year (Lancet. 2016 Sep 3;388[10048]974-82).
“We hope this treatment will have the collateral effect of improving cardiovascular disease outcomes, but we don’t know that yet. The initial target will be patients with apnea-hypopnea episodes that affect their quality of life,” Dr. Goldberg said.
The apparent safety of this approach for treating central sleep apnea may relate to its mechanism of action, he suggested. The mortality-boosting effect of adaptive servo-ventilation may correlate with the positive pressure it creates in a patient’s chest that perhaps causes myocardial stress or hemodynamic problems. In contrast, phrenic nerve stimulation produces diaphragm motion that mimics normal breathing and creates negative chest pressure. “A lot of hypothesis generation needs to happen to better understand the underlying physiology,” Dr. Goldberg conceded.
At the end of the 6-month period that compared active treatment with control, the heart failure subgroup also showed statistically significant benefits from treatment for several sleep metrics, including apnea-hypopnea index, the central apnea index, and oxygen desaturation, and also for daytime sleepiness measured on the Epworth Sleepiness Scale. After 12 months on active treatment, patients also showed a significant improvement over baseline in their score on the Minnesota Living With Heart Failure Questionnaire, Dr. Goldberg reported.
The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Patient-reported global assessment improved markedly or moderately in 57% of treated patients and in 9% of controls.
Data source: Subgroup analysis of the remedē System pivotal trial.
Disclosures: The trial was sponsored by Respicardia, the company developing the remedē System. Dr. Goldberg has been a consultant to and has received research funding from Respicardia. Dr. Stevenson had no relevant disclosures.
Cardio-oncology booms but awareness lags
Cardio-oncology is expanding, fed by a steadily increasing population of cancer survivors at elevated risk for a range of cardiovascular diseases and complications because of the anticancer treatments they received. Cardio-oncology’s quick growth has also been driven by the rapidly expanding universe of cancer treatments with direct or indirect adverse effects on a diverse range of cardiovascular functions.
During the past year, the field’s rapid evolution has featured the first formal diagnostic and care standards in two iterations: A position paper on the cardiovascular toxicities of cancer treatment from the European Society of Cardiology (ESC), released in August 2016 (Eur Heart J. 2016 Sept 21;37[36]:2766-801); and a guideline for preventing and monitoring cardiac dysfunction in adult cancer survivors, issued last December by the American Society of Clinical Oncology (ASCO) and endorsed by the American Heart Association (J Clin Oncol. 2017 March 10;35[8]:893-913), but notably not endorsed by the American College of Cardiology, despite having an ACC representative on the guideline panel. In 2015, the ACC started a Cardio-Oncology Section, one of 20 special-interest sections it maintains, and by mid-2017 the section had some 500 members.
“I’ve had recent conversations with cardiologists who said ‘I’m not sure what cardio-oncology is,’ ” said Tomas G. Neilan, MD, director of the cardio-oncology program at Massachusetts General Hospital in Boston.
More than just heart failure
A few decades ago, in the primordial days of cardio-oncology, the concept of cardiovascular damage during cancer therapy focused entirely on myocardial damage caused by anthracyclines and chest radiation, a concern that eventually expanded to include trastuzumab (Herceptin) and other agents that target the human epidermal growth factor receptor 2 (HER2). These treatments cause significantly reduced left ventricular ejection fractions and heart failure in a significant minority of treated patients. Patients who receive combined treatment with an anthracycline and trastuzumab are at the highest risk for developing heart failure with reduced ejection fraction, but even among patients treated with this combination, fewer than 5% develop outright heart failure.
While this parochial view of cardio-oncology has recently shifted, it remains true that myocardial damage from a relatively large cumulative anthracycline dose, or from radiation, causes some of the most extreme cases of cardiovascular adverse effects and remains an ongoing problem as these treatments stay front line for selected cancer patients.
But some of the recent burgeoning of cardio-oncology has followed the recognition that many other drugs and drug classes can cause a spectrum of adverse cardiovascular effects.
“There has been a significant focus on heart failure and cardiomyopathy due to anthracyclines and HER2-targeted therapies. I think the field will continue to evolve over the next 5 years to focus on other cardiovascular complications, including arrhythmias and vascular disease,” observed Michael Fradley, MD, director of cardio-oncology at Moffitt Cancer Center in Tampa. “In addition, there will be an increased focus on targeted drugs and immunotherapies,” agents that Dr. Fradley said “have many unique cardiovascular complications. We need additional guidelines regarding the management of a variety of cardiotoxicities as well as long-term monitoring strategies.”
In a review article Dr. Moslehi published toward the end of 2016, he fleshed out the wider scope of adverse cardiovascular effects from cancer therapies, noting that the vascular endothelial growth factor (VEGF) signaling pathway inhibitors, drugs such as bevacizumab (Avastin) and aflibercept (Zaltrap), have been documented to cause hypertension, arterial thromboembolic events, and cardiomyopathy; and that tyrosine kinase inhibitors have been shown to cause vascular events, QT interval prolongation, and cerebral and peripheral vascular events (N Engl J Med. 2016 Oct 13;375[15]:1457-67).
In his own recent review, Dr. Fradley highlighted adverse cardiovascular effects from additional anticancer drug classes, including proteasome inhibitors, which can trigger hypertension and cardiomyopathy; immunomodulators, implicated in causing both venous and arterial thromboembolism; and the immune checkpoint inhibitors, linked with myocarditis, arrhythmias, hypotension, and myocardial ischemia (Eur Heart J. 2016 Sept 21;37[36]:2740-2). A similarly broad spectrum of adverse cardiovascular effects linked with a wide range of anticancer treatments also appeared in the ESC 2016 position paper on cancer treatments.
But while the range of cancer treatments that can have some impact on the cardiovascular system is strikingly large, experts uniformly caution that far from every patient treated for cancer needs an immediate cardiology consult and work-up, especially when the cancers appear in young adults.
“We’re not quite at the point where every cancer patient needs to be seen by a cardiologist or cardio-oncologist,” Dr. Fradley noted in an interview.
“If a patient develops hypertension while on treatment I refer them to a PCP or cardiologist. I don’t treat hypertension myself. But if a patient is ‘normal’ they don’t need a cardiology assessment up front. It’s impossible to refer all patients, especially younger patients, with current resources. There are too many patients who receive cardiotoxic therapies to refer everyone. I involve the cardiologist once there is evidence of damage,”she explained.
Cardio-oncology centers or community practice?
The rise of cardio-oncology, especially over the last decade or so, has given rise to a new academic niche, the cardio-oncology clinic. Starting from almost no programs a few years ago, by 2016 one tally put the total number of U.S. self-designated cardio-oncology centers at about 40 (Heart Fail Clin. 2017 April;13[2]:347-55), and that number undoubtedly grew even more during the year since. While these programs promote and advance the nascent subspecialty of cardio-oncology, and provide a foundation for development of formalized training programs, many experts see a clear hierarchy of risk that distinguishes the patients who should ideally be managed at these focused, multidisciplinary programs from the lower-risk patients who probably do fine under the care of just their oncologist or their oncologist in collaboration with a community cardiologist or primary care physician.
“The cardio-oncology community recognizes that it is nice to have programs at academic centers but it’s more important to deliver this care in the community,” said Dr. Lenihan. “Many cancer patients have no prior history of cardiovascular disease. These low-risk patients don’t necessarily need a cardio-oncologist. They may need to have their blood pressure managed more effectively or receive other preventive care, but that can certainly be done locally. There are low-risk patients who don’t need to go to a major center.” Dr. Lenihan and other cardio-oncologists see the majority of cancer patients as low risk when it comes to cardiovascular complications.
But it’s different when patients receive an anthracycline or an anthracycline plus trastuzumab. “This high-risk population is best seen at a cardio-oncology center.” Dr. Lenihan also included in this high-risk subgroup patients treated with mediastinal radiation, an option often used during the 1980s-2000s.
“Any time a patient receives treatment with the potential to cause a cardiovascular effect, which is pretty much any drug that now comes out, you need an accurate baseline assessment. But that doesn’t mean you need do anything different; you still treat the patient’s cancer. A thorough baseline assessment is a necessity, but it does not need to be done at a cardio-oncology center,” Dr. Lenihan said in an interview.
“For the vast majority of patients, care can be at community hospitals, similar to the delivery of the vast majority of oncology care. Some patients need referral to tertiary cardiology centers for advanced heart failure or to undergo advanced procedures, but that is a very small percentage of patients,” said Ana Barac, MD, director of the cardio-oncology program at the MedStar Heart Institute in Washington, and chair of the ACC’s Cardio-Oncology Section.
“Patients receiving more novel or unusual therapies, and those participating in trials” are appropriate for centers, while community care by a cardiologist and oncologist should suffice for more routine patients, said Dr. Fradley.
“Cardio-oncology centers are good for patients with type I damage from anthracycline treatment, especially patients who already had underlying heart disease,” said Michael S. Ewer, MD, a cardiologist and professor of medicine at MD Anderson Cancer Center in Houston. Specialist centers are also for patients with cardiovascular risk factors: older age, diabetes, preexisting coronary artery disease, and patients who receive cardiotoxic type I therapy (J Clin Oncol. 2005 May;23[13]:2900-2). Also, patients with a significant, immediate cardiac reaction to treatment, and those with an unexpected cardiac reaction, Dr. Ewer said.
A somewhat more expansive view of the typical cardio-oncology patient came from Dr. Neilan, based on the patients he sees at his program in Boston. Dr. Neilan estimated that roughly 60%-70% of his patients first present while they undergo active cancer treatment, with another 20% coming to the program as cancer survivors, and a small percentage of patients showing up for cardiology assessments and treatments without a cancer history. Among those with a cancer history, he guessed that perhaps 10%-20% were treated with an anthracycline, at least 10% received trastuzumab, and about 10% received radiation treatment. “I also see a lot of patients with complications from treatment” with tyrosine kinase inhibitors, VEGF inhibitors, and immunotherapies. “I don’t see a lot of patients for cardiovascular disease assessment before they start cancer therapy,” Dr. Neilan added.
Cardio-oncology heads toward a new cardiology subspecialty
These views of how cardio-oncology is practiced in the real world raise a question about the role of the growing roster of U.S. cardio-oncology programs. If most cancer patients can have their cardiology needs taken care of in the community, how do all the academic programs fit in? The answer seems to be that they model successful oncology and cardiology collaborations, provide a training ground for physicians from both specialties to learn how to collaborate, and serve as the home for research that broadens the field’s evidence base and moves knowledge forward.
“Education and partnerships with oncology teams is the key,” said Dr. Barac. “Our traditional subspecialty training focused on ‘treating cancer’ and ‘treating cardiovascular disease.’ Learning about and seeing effective partnerships during training” is the best model to foster cardiology and oncology partnerships among early-career physicians, she suggested.
“What is the spectrum of knowledge required to be proficient in cardio-oncology, and how do we enhance training at the resident or fellowship level? How do we get [all cardiology] trainees exposed to this knowledge?” wondered Dr. Lenihan, who viewed cardio-oncology programs as a way to meet these needs. “Cardio-oncology is not an established subspecialty. A goal is to establish training requirements and expand training opportunities. And the whole field needs to contribute to clinical research. We need cardio-oncologists to share their experience and improve our level of research.”
ASCO’s cardiac dysfunction practice guideline, first released last December and formally published in March, is likely helping to further entrench cardio-oncology as a new subspecialty. The guideline was “a remarkable step forward,” said Dr. Barac. In addition to establishing a U.S. standard of care for preventing and monitoring cardiac dysfunction in cancer patients, “I use it as a guide for creation of referral pathways with my oncology colleagues, as well as in education of cardiovascular and oncology trainees,” she said in an interview.
Though produced primarily through ASCO’s leadership, the target audience for the guideline seems to be as much cardiologists as it is oncologists. Dissemination of the guideline to cardiologists snagged when it failed to appear in the cardiology literature. That wasn’t the original plan, said guideline participants.
“Before we started, it was agreed that both ASCO and the ACC would publish it. We had a [letter] signed by the president of the ACC saying the ACC would publish it,” recalled Dr. Lenihan, a guideline coauthor. “After all the details were settled, the ACC bailed. They said that they had changed their organizational structure and that they wouldn’t publish the guideline even though they had agreed to.” Not having the guideline appear simultaneously in the cardiology literature “hinders getting the message to the cardiology community,” he said, a sentiment echoed by other cardio-oncologists.
“I served as the ACC representative on the guideline, and the lack of ACC endorsement was the unfortunate consequence of approval and publication timing that coincided with restructuring of the ACC committees,” said Dr. Barac. “It absolutely does not reflect a lack of interest from the ACC.” As an example of the College’s commitment example, she cited an ACC 1.5-day educational course on cardiovascular care of oncology patients held for the first time in February 2017 and scheduled for a second edition next February.
Publication of the guideline in a cardiology journal “would indeed help dissemination among U.S. cardiologists,” agreed Pamela S. Douglas, MD, professor of medicine at Duke University in Durham, N.C., and another of the several cardiologists who served on the ASCO guideline’s panel.
Further advancing awareness of patients with cardio-oncology issues, what Dr. Moslehi has called “an emerging epidemic,” seems the most fundamental of the goals currently advanced by many active in this field.
One step to grow the subspecialty that he and his associates at Vanderbilt have taken is to start this year a formally recognized fellowship program in cardio-oncology; an initial class of three cardiologists started in the program this summer. The Vanderbilt group also plans to launch a website before the end of 2017 that will include an oncology-drug database that compiles all available information on each agent’s cardiovascular effects. The planned website will aggregate links to all existing cardio-oncology programs.
“We will absolutely see the field grow,” said Dr. Swain. “It has only sprung up in the past 10 or so years. It is now getting recognition, people are being trained in cardio-oncology, and it will grow as a subspecialty. It’s very exciting, and it’s better for patients.”
“A cardiologist with no cancer patients or survivors in their practice is unheard of; many cardiologists just don’t realize that,” Dr. Lenihan said. At least 10%-15% of the U.S. population in their 60s or older has a cancer history, he noted. The common mindset among cardiologists has been that cancer patients and survivors are not among their patients.
“It’s unlikely that a busy cardiology practice has no cancer survivors or active cancer patients,” Dr. Douglas suggested. When this happens, a likely explanations is that the cardiologist simply failed to elicit a completely comprehensive history from the practice’s patient roster. And even a cardiology practice today that includes no cancer patients or survivors will likely see some turning up soon, she predicted, because so many are receiving cardiovascular-toxic therapies and then surviving longer than ever before.
“What oncologists and cardiologists want to do is to optimize oncologic outcomes but with an acceptable adverse event profile. The cardio-oncologist helps push that envelope. The goal is not to eliminate cardiac events at the expense of oncologic outcomes, but to shift the balance to fewer and less severe cardiac events without unduly compromising oncologic outcomes,” explained Dr. Ewer. Cardio-oncology grapples with one of the core challenges of medicine, how to balance the potential risks from treatment against its potential benefits, he observed.
Dr. Neilan has been a consultant to Ariad and Takeda. Dr. Lenihan has been a consultant to Janssen and Roche and has received research funding from Takeda. Dr. Moslehi has been a consultant to Acceleron, Ariad, Bristol-Myers Squibb, Incyte, Pfizer, Takeda/Millennium, Verastem and Vertex. Dr. Ewer, Dr. Fradley, and Dr. Barac had no relevant disclosures. Dr. Swain has been a consultant to Genentech and Roche. Dr. Douglas has been a consultant to CardioDx, Interleukin Genetics, and Omicia, and has an ownership interest in CardioDx.
[email protected]
On Twitter @mitchelzoler
Cardio-oncology is expanding, fed by a steadily increasing population of cancer survivors at elevated risk for a range of cardiovascular diseases and complications because of the anticancer treatments they received. Cardio-oncology’s quick growth has also been driven by the rapidly expanding universe of cancer treatments with direct or indirect adverse effects on a diverse range of cardiovascular functions.
During the past year, the field’s rapid evolution has featured the first formal diagnostic and care standards in two iterations: A position paper on the cardiovascular toxicities of cancer treatment from the European Society of Cardiology (ESC), released in August 2016 (Eur Heart J. 2016 Sept 21;37[36]:2766-801); and a guideline for preventing and monitoring cardiac dysfunction in adult cancer survivors, issued last December by the American Society of Clinical Oncology (ASCO) and endorsed by the American Heart Association (J Clin Oncol. 2017 March 10;35[8]:893-913), but notably not endorsed by the American College of Cardiology, despite having an ACC representative on the guideline panel. In 2015, the ACC started a Cardio-Oncology Section, one of 20 special-interest sections it maintains, and by mid-2017 the section had some 500 members.
“I’ve had recent conversations with cardiologists who said ‘I’m not sure what cardio-oncology is,’ ” said Tomas G. Neilan, MD, director of the cardio-oncology program at Massachusetts General Hospital in Boston.
More than just heart failure
A few decades ago, in the primordial days of cardio-oncology, the concept of cardiovascular damage during cancer therapy focused entirely on myocardial damage caused by anthracyclines and chest radiation, a concern that eventually expanded to include trastuzumab (Herceptin) and other agents that target the human epidermal growth factor receptor 2 (HER2). These treatments cause significantly reduced left ventricular ejection fractions and heart failure in a significant minority of treated patients. Patients who receive combined treatment with an anthracycline and trastuzumab are at the highest risk for developing heart failure with reduced ejection fraction, but even among patients treated with this combination, fewer than 5% develop outright heart failure.
While this parochial view of cardio-oncology has recently shifted, it remains true that myocardial damage from a relatively large cumulative anthracycline dose, or from radiation, causes some of the most extreme cases of cardiovascular adverse effects and remains an ongoing problem as these treatments stay front line for selected cancer patients.
But some of the recent burgeoning of cardio-oncology has followed the recognition that many other drugs and drug classes can cause a spectrum of adverse cardiovascular effects.
“There has been a significant focus on heart failure and cardiomyopathy due to anthracyclines and HER2-targeted therapies. I think the field will continue to evolve over the next 5 years to focus on other cardiovascular complications, including arrhythmias and vascular disease,” observed Michael Fradley, MD, director of cardio-oncology at Moffitt Cancer Center in Tampa. “In addition, there will be an increased focus on targeted drugs and immunotherapies,” agents that Dr. Fradley said “have many unique cardiovascular complications. We need additional guidelines regarding the management of a variety of cardiotoxicities as well as long-term monitoring strategies.”
In a review article Dr. Moslehi published toward the end of 2016, he fleshed out the wider scope of adverse cardiovascular effects from cancer therapies, noting that the vascular endothelial growth factor (VEGF) signaling pathway inhibitors, drugs such as bevacizumab (Avastin) and aflibercept (Zaltrap), have been documented to cause hypertension, arterial thromboembolic events, and cardiomyopathy; and that tyrosine kinase inhibitors have been shown to cause vascular events, QT interval prolongation, and cerebral and peripheral vascular events (N Engl J Med. 2016 Oct 13;375[15]:1457-67).
In his own recent review, Dr. Fradley highlighted adverse cardiovascular effects from additional anticancer drug classes, including proteasome inhibitors, which can trigger hypertension and cardiomyopathy; immunomodulators, implicated in causing both venous and arterial thromboembolism; and the immune checkpoint inhibitors, linked with myocarditis, arrhythmias, hypotension, and myocardial ischemia (Eur Heart J. 2016 Sept 21;37[36]:2740-2). A similarly broad spectrum of adverse cardiovascular effects linked with a wide range of anticancer treatments also appeared in the ESC 2016 position paper on cancer treatments.
But while the range of cancer treatments that can have some impact on the cardiovascular system is strikingly large, experts uniformly caution that far from every patient treated for cancer needs an immediate cardiology consult and work-up, especially when the cancers appear in young adults.
“We’re not quite at the point where every cancer patient needs to be seen by a cardiologist or cardio-oncologist,” Dr. Fradley noted in an interview.
“If a patient develops hypertension while on treatment I refer them to a PCP or cardiologist. I don’t treat hypertension myself. But if a patient is ‘normal’ they don’t need a cardiology assessment up front. It’s impossible to refer all patients, especially younger patients, with current resources. There are too many patients who receive cardiotoxic therapies to refer everyone. I involve the cardiologist once there is evidence of damage,”she explained.
Cardio-oncology centers or community practice?
The rise of cardio-oncology, especially over the last decade or so, has given rise to a new academic niche, the cardio-oncology clinic. Starting from almost no programs a few years ago, by 2016 one tally put the total number of U.S. self-designated cardio-oncology centers at about 40 (Heart Fail Clin. 2017 April;13[2]:347-55), and that number undoubtedly grew even more during the year since. While these programs promote and advance the nascent subspecialty of cardio-oncology, and provide a foundation for development of formalized training programs, many experts see a clear hierarchy of risk that distinguishes the patients who should ideally be managed at these focused, multidisciplinary programs from the lower-risk patients who probably do fine under the care of just their oncologist or their oncologist in collaboration with a community cardiologist or primary care physician.
“The cardio-oncology community recognizes that it is nice to have programs at academic centers but it’s more important to deliver this care in the community,” said Dr. Lenihan. “Many cancer patients have no prior history of cardiovascular disease. These low-risk patients don’t necessarily need a cardio-oncologist. They may need to have their blood pressure managed more effectively or receive other preventive care, but that can certainly be done locally. There are low-risk patients who don’t need to go to a major center.” Dr. Lenihan and other cardio-oncologists see the majority of cancer patients as low risk when it comes to cardiovascular complications.
But it’s different when patients receive an anthracycline or an anthracycline plus trastuzumab. “This high-risk population is best seen at a cardio-oncology center.” Dr. Lenihan also included in this high-risk subgroup patients treated with mediastinal radiation, an option often used during the 1980s-2000s.
“Any time a patient receives treatment with the potential to cause a cardiovascular effect, which is pretty much any drug that now comes out, you need an accurate baseline assessment. But that doesn’t mean you need do anything different; you still treat the patient’s cancer. A thorough baseline assessment is a necessity, but it does not need to be done at a cardio-oncology center,” Dr. Lenihan said in an interview.
“For the vast majority of patients, care can be at community hospitals, similar to the delivery of the vast majority of oncology care. Some patients need referral to tertiary cardiology centers for advanced heart failure or to undergo advanced procedures, but that is a very small percentage of patients,” said Ana Barac, MD, director of the cardio-oncology program at the MedStar Heart Institute in Washington, and chair of the ACC’s Cardio-Oncology Section.
“Patients receiving more novel or unusual therapies, and those participating in trials” are appropriate for centers, while community care by a cardiologist and oncologist should suffice for more routine patients, said Dr. Fradley.
“Cardio-oncology centers are good for patients with type I damage from anthracycline treatment, especially patients who already had underlying heart disease,” said Michael S. Ewer, MD, a cardiologist and professor of medicine at MD Anderson Cancer Center in Houston. Specialist centers are also for patients with cardiovascular risk factors: older age, diabetes, preexisting coronary artery disease, and patients who receive cardiotoxic type I therapy (J Clin Oncol. 2005 May;23[13]:2900-2). Also, patients with a significant, immediate cardiac reaction to treatment, and those with an unexpected cardiac reaction, Dr. Ewer said.
A somewhat more expansive view of the typical cardio-oncology patient came from Dr. Neilan, based on the patients he sees at his program in Boston. Dr. Neilan estimated that roughly 60%-70% of his patients first present while they undergo active cancer treatment, with another 20% coming to the program as cancer survivors, and a small percentage of patients showing up for cardiology assessments and treatments without a cancer history. Among those with a cancer history, he guessed that perhaps 10%-20% were treated with an anthracycline, at least 10% received trastuzumab, and about 10% received radiation treatment. “I also see a lot of patients with complications from treatment” with tyrosine kinase inhibitors, VEGF inhibitors, and immunotherapies. “I don’t see a lot of patients for cardiovascular disease assessment before they start cancer therapy,” Dr. Neilan added.
Cardio-oncology heads toward a new cardiology subspecialty
These views of how cardio-oncology is practiced in the real world raise a question about the role of the growing roster of U.S. cardio-oncology programs. If most cancer patients can have their cardiology needs taken care of in the community, how do all the academic programs fit in? The answer seems to be that they model successful oncology and cardiology collaborations, provide a training ground for physicians from both specialties to learn how to collaborate, and serve as the home for research that broadens the field’s evidence base and moves knowledge forward.
“Education and partnerships with oncology teams is the key,” said Dr. Barac. “Our traditional subspecialty training focused on ‘treating cancer’ and ‘treating cardiovascular disease.’ Learning about and seeing effective partnerships during training” is the best model to foster cardiology and oncology partnerships among early-career physicians, she suggested.
“What is the spectrum of knowledge required to be proficient in cardio-oncology, and how do we enhance training at the resident or fellowship level? How do we get [all cardiology] trainees exposed to this knowledge?” wondered Dr. Lenihan, who viewed cardio-oncology programs as a way to meet these needs. “Cardio-oncology is not an established subspecialty. A goal is to establish training requirements and expand training opportunities. And the whole field needs to contribute to clinical research. We need cardio-oncologists to share their experience and improve our level of research.”
ASCO’s cardiac dysfunction practice guideline, first released last December and formally published in March, is likely helping to further entrench cardio-oncology as a new subspecialty. The guideline was “a remarkable step forward,” said Dr. Barac. In addition to establishing a U.S. standard of care for preventing and monitoring cardiac dysfunction in cancer patients, “I use it as a guide for creation of referral pathways with my oncology colleagues, as well as in education of cardiovascular and oncology trainees,” she said in an interview.
Though produced primarily through ASCO’s leadership, the target audience for the guideline seems to be as much cardiologists as it is oncologists. Dissemination of the guideline to cardiologists snagged when it failed to appear in the cardiology literature. That wasn’t the original plan, said guideline participants.
“Before we started, it was agreed that both ASCO and the ACC would publish it. We had a [letter] signed by the president of the ACC saying the ACC would publish it,” recalled Dr. Lenihan, a guideline coauthor. “After all the details were settled, the ACC bailed. They said that they had changed their organizational structure and that they wouldn’t publish the guideline even though they had agreed to.” Not having the guideline appear simultaneously in the cardiology literature “hinders getting the message to the cardiology community,” he said, a sentiment echoed by other cardio-oncologists.
“I served as the ACC representative on the guideline, and the lack of ACC endorsement was the unfortunate consequence of approval and publication timing that coincided with restructuring of the ACC committees,” said Dr. Barac. “It absolutely does not reflect a lack of interest from the ACC.” As an example of the College’s commitment example, she cited an ACC 1.5-day educational course on cardiovascular care of oncology patients held for the first time in February 2017 and scheduled for a second edition next February.
Publication of the guideline in a cardiology journal “would indeed help dissemination among U.S. cardiologists,” agreed Pamela S. Douglas, MD, professor of medicine at Duke University in Durham, N.C., and another of the several cardiologists who served on the ASCO guideline’s panel.
Further advancing awareness of patients with cardio-oncology issues, what Dr. Moslehi has called “an emerging epidemic,” seems the most fundamental of the goals currently advanced by many active in this field.
One step to grow the subspecialty that he and his associates at Vanderbilt have taken is to start this year a formally recognized fellowship program in cardio-oncology; an initial class of three cardiologists started in the program this summer. The Vanderbilt group also plans to launch a website before the end of 2017 that will include an oncology-drug database that compiles all available information on each agent’s cardiovascular effects. The planned website will aggregate links to all existing cardio-oncology programs.
“We will absolutely see the field grow,” said Dr. Swain. “It has only sprung up in the past 10 or so years. It is now getting recognition, people are being trained in cardio-oncology, and it will grow as a subspecialty. It’s very exciting, and it’s better for patients.”
“A cardiologist with no cancer patients or survivors in their practice is unheard of; many cardiologists just don’t realize that,” Dr. Lenihan said. At least 10%-15% of the U.S. population in their 60s or older has a cancer history, he noted. The common mindset among cardiologists has been that cancer patients and survivors are not among their patients.
“It’s unlikely that a busy cardiology practice has no cancer survivors or active cancer patients,” Dr. Douglas suggested. When this happens, a likely explanations is that the cardiologist simply failed to elicit a completely comprehensive history from the practice’s patient roster. And even a cardiology practice today that includes no cancer patients or survivors will likely see some turning up soon, she predicted, because so many are receiving cardiovascular-toxic therapies and then surviving longer than ever before.
“What oncologists and cardiologists want to do is to optimize oncologic outcomes but with an acceptable adverse event profile. The cardio-oncologist helps push that envelope. The goal is not to eliminate cardiac events at the expense of oncologic outcomes, but to shift the balance to fewer and less severe cardiac events without unduly compromising oncologic outcomes,” explained Dr. Ewer. Cardio-oncology grapples with one of the core challenges of medicine, how to balance the potential risks from treatment against its potential benefits, he observed.
Dr. Neilan has been a consultant to Ariad and Takeda. Dr. Lenihan has been a consultant to Janssen and Roche and has received research funding from Takeda. Dr. Moslehi has been a consultant to Acceleron, Ariad, Bristol-Myers Squibb, Incyte, Pfizer, Takeda/Millennium, Verastem and Vertex. Dr. Ewer, Dr. Fradley, and Dr. Barac had no relevant disclosures. Dr. Swain has been a consultant to Genentech and Roche. Dr. Douglas has been a consultant to CardioDx, Interleukin Genetics, and Omicia, and has an ownership interest in CardioDx.
[email protected]
On Twitter @mitchelzoler
Cardio-oncology is expanding, fed by a steadily increasing population of cancer survivors at elevated risk for a range of cardiovascular diseases and complications because of the anticancer treatments they received. Cardio-oncology’s quick growth has also been driven by the rapidly expanding universe of cancer treatments with direct or indirect adverse effects on a diverse range of cardiovascular functions.
During the past year, the field’s rapid evolution has featured the first formal diagnostic and care standards in two iterations: A position paper on the cardiovascular toxicities of cancer treatment from the European Society of Cardiology (ESC), released in August 2016 (Eur Heart J. 2016 Sept 21;37[36]:2766-801); and a guideline for preventing and monitoring cardiac dysfunction in adult cancer survivors, issued last December by the American Society of Clinical Oncology (ASCO) and endorsed by the American Heart Association (J Clin Oncol. 2017 March 10;35[8]:893-913), but notably not endorsed by the American College of Cardiology, despite having an ACC representative on the guideline panel. In 2015, the ACC started a Cardio-Oncology Section, one of 20 special-interest sections it maintains, and by mid-2017 the section had some 500 members.
“I’ve had recent conversations with cardiologists who said ‘I’m not sure what cardio-oncology is,’ ” said Tomas G. Neilan, MD, director of the cardio-oncology program at Massachusetts General Hospital in Boston.
More than just heart failure
A few decades ago, in the primordial days of cardio-oncology, the concept of cardiovascular damage during cancer therapy focused entirely on myocardial damage caused by anthracyclines and chest radiation, a concern that eventually expanded to include trastuzumab (Herceptin) and other agents that target the human epidermal growth factor receptor 2 (HER2). These treatments cause significantly reduced left ventricular ejection fractions and heart failure in a significant minority of treated patients. Patients who receive combined treatment with an anthracycline and trastuzumab are at the highest risk for developing heart failure with reduced ejection fraction, but even among patients treated with this combination, fewer than 5% develop outright heart failure.
While this parochial view of cardio-oncology has recently shifted, it remains true that myocardial damage from a relatively large cumulative anthracycline dose, or from radiation, causes some of the most extreme cases of cardiovascular adverse effects and remains an ongoing problem as these treatments stay front line for selected cancer patients.
But some of the recent burgeoning of cardio-oncology has followed the recognition that many other drugs and drug classes can cause a spectrum of adverse cardiovascular effects.
“There has been a significant focus on heart failure and cardiomyopathy due to anthracyclines and HER2-targeted therapies. I think the field will continue to evolve over the next 5 years to focus on other cardiovascular complications, including arrhythmias and vascular disease,” observed Michael Fradley, MD, director of cardio-oncology at Moffitt Cancer Center in Tampa. “In addition, there will be an increased focus on targeted drugs and immunotherapies,” agents that Dr. Fradley said “have many unique cardiovascular complications. We need additional guidelines regarding the management of a variety of cardiotoxicities as well as long-term monitoring strategies.”
In a review article Dr. Moslehi published toward the end of 2016, he fleshed out the wider scope of adverse cardiovascular effects from cancer therapies, noting that the vascular endothelial growth factor (VEGF) signaling pathway inhibitors, drugs such as bevacizumab (Avastin) and aflibercept (Zaltrap), have been documented to cause hypertension, arterial thromboembolic events, and cardiomyopathy; and that tyrosine kinase inhibitors have been shown to cause vascular events, QT interval prolongation, and cerebral and peripheral vascular events (N Engl J Med. 2016 Oct 13;375[15]:1457-67).
In his own recent review, Dr. Fradley highlighted adverse cardiovascular effects from additional anticancer drug classes, including proteasome inhibitors, which can trigger hypertension and cardiomyopathy; immunomodulators, implicated in causing both venous and arterial thromboembolism; and the immune checkpoint inhibitors, linked with myocarditis, arrhythmias, hypotension, and myocardial ischemia (Eur Heart J. 2016 Sept 21;37[36]:2740-2). A similarly broad spectrum of adverse cardiovascular effects linked with a wide range of anticancer treatments also appeared in the ESC 2016 position paper on cancer treatments.
But while the range of cancer treatments that can have some impact on the cardiovascular system is strikingly large, experts uniformly caution that far from every patient treated for cancer needs an immediate cardiology consult and work-up, especially when the cancers appear in young adults.
“We’re not quite at the point where every cancer patient needs to be seen by a cardiologist or cardio-oncologist,” Dr. Fradley noted in an interview.
“If a patient develops hypertension while on treatment I refer them to a PCP or cardiologist. I don’t treat hypertension myself. But if a patient is ‘normal’ they don’t need a cardiology assessment up front. It’s impossible to refer all patients, especially younger patients, with current resources. There are too many patients who receive cardiotoxic therapies to refer everyone. I involve the cardiologist once there is evidence of damage,”she explained.
Cardio-oncology centers or community practice?
The rise of cardio-oncology, especially over the last decade or so, has given rise to a new academic niche, the cardio-oncology clinic. Starting from almost no programs a few years ago, by 2016 one tally put the total number of U.S. self-designated cardio-oncology centers at about 40 (Heart Fail Clin. 2017 April;13[2]:347-55), and that number undoubtedly grew even more during the year since. While these programs promote and advance the nascent subspecialty of cardio-oncology, and provide a foundation for development of formalized training programs, many experts see a clear hierarchy of risk that distinguishes the patients who should ideally be managed at these focused, multidisciplinary programs from the lower-risk patients who probably do fine under the care of just their oncologist or their oncologist in collaboration with a community cardiologist or primary care physician.
“The cardio-oncology community recognizes that it is nice to have programs at academic centers but it’s more important to deliver this care in the community,” said Dr. Lenihan. “Many cancer patients have no prior history of cardiovascular disease. These low-risk patients don’t necessarily need a cardio-oncologist. They may need to have their blood pressure managed more effectively or receive other preventive care, but that can certainly be done locally. There are low-risk patients who don’t need to go to a major center.” Dr. Lenihan and other cardio-oncologists see the majority of cancer patients as low risk when it comes to cardiovascular complications.
But it’s different when patients receive an anthracycline or an anthracycline plus trastuzumab. “This high-risk population is best seen at a cardio-oncology center.” Dr. Lenihan also included in this high-risk subgroup patients treated with mediastinal radiation, an option often used during the 1980s-2000s.
“Any time a patient receives treatment with the potential to cause a cardiovascular effect, which is pretty much any drug that now comes out, you need an accurate baseline assessment. But that doesn’t mean you need do anything different; you still treat the patient’s cancer. A thorough baseline assessment is a necessity, but it does not need to be done at a cardio-oncology center,” Dr. Lenihan said in an interview.
“For the vast majority of patients, care can be at community hospitals, similar to the delivery of the vast majority of oncology care. Some patients need referral to tertiary cardiology centers for advanced heart failure or to undergo advanced procedures, but that is a very small percentage of patients,” said Ana Barac, MD, director of the cardio-oncology program at the MedStar Heart Institute in Washington, and chair of the ACC’s Cardio-Oncology Section.
“Patients receiving more novel or unusual therapies, and those participating in trials” are appropriate for centers, while community care by a cardiologist and oncologist should suffice for more routine patients, said Dr. Fradley.
“Cardio-oncology centers are good for patients with type I damage from anthracycline treatment, especially patients who already had underlying heart disease,” said Michael S. Ewer, MD, a cardiologist and professor of medicine at MD Anderson Cancer Center in Houston. Specialist centers are also for patients with cardiovascular risk factors: older age, diabetes, preexisting coronary artery disease, and patients who receive cardiotoxic type I therapy (J Clin Oncol. 2005 May;23[13]:2900-2). Also, patients with a significant, immediate cardiac reaction to treatment, and those with an unexpected cardiac reaction, Dr. Ewer said.
A somewhat more expansive view of the typical cardio-oncology patient came from Dr. Neilan, based on the patients he sees at his program in Boston. Dr. Neilan estimated that roughly 60%-70% of his patients first present while they undergo active cancer treatment, with another 20% coming to the program as cancer survivors, and a small percentage of patients showing up for cardiology assessments and treatments without a cancer history. Among those with a cancer history, he guessed that perhaps 10%-20% were treated with an anthracycline, at least 10% received trastuzumab, and about 10% received radiation treatment. “I also see a lot of patients with complications from treatment” with tyrosine kinase inhibitors, VEGF inhibitors, and immunotherapies. “I don’t see a lot of patients for cardiovascular disease assessment before they start cancer therapy,” Dr. Neilan added.
Cardio-oncology heads toward a new cardiology subspecialty
These views of how cardio-oncology is practiced in the real world raise a question about the role of the growing roster of U.S. cardio-oncology programs. If most cancer patients can have their cardiology needs taken care of in the community, how do all the academic programs fit in? The answer seems to be that they model successful oncology and cardiology collaborations, provide a training ground for physicians from both specialties to learn how to collaborate, and serve as the home for research that broadens the field’s evidence base and moves knowledge forward.
“Education and partnerships with oncology teams is the key,” said Dr. Barac. “Our traditional subspecialty training focused on ‘treating cancer’ and ‘treating cardiovascular disease.’ Learning about and seeing effective partnerships during training” is the best model to foster cardiology and oncology partnerships among early-career physicians, she suggested.
“What is the spectrum of knowledge required to be proficient in cardio-oncology, and how do we enhance training at the resident or fellowship level? How do we get [all cardiology] trainees exposed to this knowledge?” wondered Dr. Lenihan, who viewed cardio-oncology programs as a way to meet these needs. “Cardio-oncology is not an established subspecialty. A goal is to establish training requirements and expand training opportunities. And the whole field needs to contribute to clinical research. We need cardio-oncologists to share their experience and improve our level of research.”
ASCO’s cardiac dysfunction practice guideline, first released last December and formally published in March, is likely helping to further entrench cardio-oncology as a new subspecialty. The guideline was “a remarkable step forward,” said Dr. Barac. In addition to establishing a U.S. standard of care for preventing and monitoring cardiac dysfunction in cancer patients, “I use it as a guide for creation of referral pathways with my oncology colleagues, as well as in education of cardiovascular and oncology trainees,” she said in an interview.
Though produced primarily through ASCO’s leadership, the target audience for the guideline seems to be as much cardiologists as it is oncologists. Dissemination of the guideline to cardiologists snagged when it failed to appear in the cardiology literature. That wasn’t the original plan, said guideline participants.
“Before we started, it was agreed that both ASCO and the ACC would publish it. We had a [letter] signed by the president of the ACC saying the ACC would publish it,” recalled Dr. Lenihan, a guideline coauthor. “After all the details were settled, the ACC bailed. They said that they had changed their organizational structure and that they wouldn’t publish the guideline even though they had agreed to.” Not having the guideline appear simultaneously in the cardiology literature “hinders getting the message to the cardiology community,” he said, a sentiment echoed by other cardio-oncologists.
“I served as the ACC representative on the guideline, and the lack of ACC endorsement was the unfortunate consequence of approval and publication timing that coincided with restructuring of the ACC committees,” said Dr. Barac. “It absolutely does not reflect a lack of interest from the ACC.” As an example of the College’s commitment example, she cited an ACC 1.5-day educational course on cardiovascular care of oncology patients held for the first time in February 2017 and scheduled for a second edition next February.
Publication of the guideline in a cardiology journal “would indeed help dissemination among U.S. cardiologists,” agreed Pamela S. Douglas, MD, professor of medicine at Duke University in Durham, N.C., and another of the several cardiologists who served on the ASCO guideline’s panel.
Further advancing awareness of patients with cardio-oncology issues, what Dr. Moslehi has called “an emerging epidemic,” seems the most fundamental of the goals currently advanced by many active in this field.
One step to grow the subspecialty that he and his associates at Vanderbilt have taken is to start this year a formally recognized fellowship program in cardio-oncology; an initial class of three cardiologists started in the program this summer. The Vanderbilt group also plans to launch a website before the end of 2017 that will include an oncology-drug database that compiles all available information on each agent’s cardiovascular effects. The planned website will aggregate links to all existing cardio-oncology programs.
“We will absolutely see the field grow,” said Dr. Swain. “It has only sprung up in the past 10 or so years. It is now getting recognition, people are being trained in cardio-oncology, and it will grow as a subspecialty. It’s very exciting, and it’s better for patients.”
“A cardiologist with no cancer patients or survivors in their practice is unheard of; many cardiologists just don’t realize that,” Dr. Lenihan said. At least 10%-15% of the U.S. population in their 60s or older has a cancer history, he noted. The common mindset among cardiologists has been that cancer patients and survivors are not among their patients.
“It’s unlikely that a busy cardiology practice has no cancer survivors or active cancer patients,” Dr. Douglas suggested. When this happens, a likely explanations is that the cardiologist simply failed to elicit a completely comprehensive history from the practice’s patient roster. And even a cardiology practice today that includes no cancer patients or survivors will likely see some turning up soon, she predicted, because so many are receiving cardiovascular-toxic therapies and then surviving longer than ever before.
“What oncologists and cardiologists want to do is to optimize oncologic outcomes but with an acceptable adverse event profile. The cardio-oncologist helps push that envelope. The goal is not to eliminate cardiac events at the expense of oncologic outcomes, but to shift the balance to fewer and less severe cardiac events without unduly compromising oncologic outcomes,” explained Dr. Ewer. Cardio-oncology grapples with one of the core challenges of medicine, how to balance the potential risks from treatment against its potential benefits, he observed.
Dr. Neilan has been a consultant to Ariad and Takeda. Dr. Lenihan has been a consultant to Janssen and Roche and has received research funding from Takeda. Dr. Moslehi has been a consultant to Acceleron, Ariad, Bristol-Myers Squibb, Incyte, Pfizer, Takeda/Millennium, Verastem and Vertex. Dr. Ewer, Dr. Fradley, and Dr. Barac had no relevant disclosures. Dr. Swain has been a consultant to Genentech and Roche. Dr. Douglas has been a consultant to CardioDx, Interleukin Genetics, and Omicia, and has an ownership interest in CardioDx.
[email protected]
On Twitter @mitchelzoler
LDL levels below 10 mg/dL shown safe, effective
BARCELONA – The maxim that lower is better for LDL cholesterol continues to hold true, even at jaw-droppingly low levels of less than 10 mg/dL in a new analysis of data from the FOURIER trial.
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial was the pivotal efficacy and safety study for the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab (Repatha) and enrolled patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of at least 70 mg/dL (N Engl J Med. 2017 May 4;376[18]:1713-22).
After a median follow-up of 26 months, the incidence of the study’s primary endpoint (cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization) dropped by a statistically significant 15% in patients with an achieved LDL cholesterol of 20-49 mg/dL, compared with patients whose 4-week LDL cholesterol was at or above 100 mg/dL (primarily patients randomized to the study’s control arm), by 24% in all patients with LDL cholesterol less than 20 mg/dL, and by 31% in the 2% of patients whose LDL cholesterol levels fell below 10 mg/dL.
These strikingly improved event rates at the lowest levels of LDL cholesterol occurred with no signal of excess adverse events, Robert P. Giugliano, MD, said at the annual congress of the European Society of Cardiology.
In contrast, the 13% of patents whose achieved LDL cholesterol was 50-69 mg/dL had an event rate just 6% below the referent group of 100 mg/dL or more, a nonsignificant difference. Existing cholesterol management guidelines that set LDL cholesterol targets for secondary prevention have used a level below 70 mg/dL as the target, such as the European Society of Cardiology’s 2016 guidelines (Eur Heart J. 2016 Oct 14;37[39]:2999-3058).
“The data suggest that we should target considerably lower LDL cholesterol than is currently recommended for our patients with atherosclerotic cardiovascular disease,” said Dr. Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston.
“Lowest is best with LDL. You don’t need a lot of LDL in the serum for normal human function,” he noted during the discussion of his report.
While FOURIER’s event curve continued to drop as LDL cholesterol fell below 10 mg/dL, the study’s wide-ranging safety assessment showed no signal of harm at the lowest levels. This “gives us some reassurance it’s safe,” he said in an interview. “We saw benefit that continued down to the lowest LDL levels, so it’s hard to pick a LDL target. I no longer feel comfortable treating my patients to just less than 70 mg/dL. I’m not sure what is the optimal LDL target, but I think it needs to be lower than that.”
To achieve such ultralow LDL levels, most patients need treatment with a PCSK9 inhibitor plus at least one and perhaps two additional cholesterol-lowering drugs, a statin and ezetimibe, he noted.
The FOURIER analyses Dr. Giugliano reported included data on the incidence during the study of 10 specific types of adverse events: noncardiovascular death, serious adverse events, adverse events leading to study discontinuation, and new onset of diabetes, cancer, cataract, neurocognitive deficit, significant liver enzyme increase, significant creatine kinase increase, and hemorrhagic stroke. The incidence of each of these was similar among the patients in five study subgroups based on achieved levels of LDL cholesterol: less than 20 mg/dL, 20-49 mg/dL, 50-69 mg/dL, 70-99 mg/dL, and 100 mg/dL or higher. In addition, the rates of both serious adverse events and adverse events leading to study discontinuation was roughly the same in the subgroup of patients with an achieved LDL cholesterol of less than 10 mg/dL as in those with an achieved LDL of at least 100 mg/dL.
Concurrently with Dr. Giugliano’s report, the results also appeared in an online article (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736[17]32290-0).
FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
[email protected]
On Twitter @mitchelzoler
BARCELONA – The maxim that lower is better for LDL cholesterol continues to hold true, even at jaw-droppingly low levels of less than 10 mg/dL in a new analysis of data from the FOURIER trial.
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial was the pivotal efficacy and safety study for the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab (Repatha) and enrolled patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of at least 70 mg/dL (N Engl J Med. 2017 May 4;376[18]:1713-22).
After a median follow-up of 26 months, the incidence of the study’s primary endpoint (cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization) dropped by a statistically significant 15% in patients with an achieved LDL cholesterol of 20-49 mg/dL, compared with patients whose 4-week LDL cholesterol was at or above 100 mg/dL (primarily patients randomized to the study’s control arm), by 24% in all patients with LDL cholesterol less than 20 mg/dL, and by 31% in the 2% of patients whose LDL cholesterol levels fell below 10 mg/dL.
These strikingly improved event rates at the lowest levels of LDL cholesterol occurred with no signal of excess adverse events, Robert P. Giugliano, MD, said at the annual congress of the European Society of Cardiology.
In contrast, the 13% of patents whose achieved LDL cholesterol was 50-69 mg/dL had an event rate just 6% below the referent group of 100 mg/dL or more, a nonsignificant difference. Existing cholesterol management guidelines that set LDL cholesterol targets for secondary prevention have used a level below 70 mg/dL as the target, such as the European Society of Cardiology’s 2016 guidelines (Eur Heart J. 2016 Oct 14;37[39]:2999-3058).
“The data suggest that we should target considerably lower LDL cholesterol than is currently recommended for our patients with atherosclerotic cardiovascular disease,” said Dr. Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston.
“Lowest is best with LDL. You don’t need a lot of LDL in the serum for normal human function,” he noted during the discussion of his report.
While FOURIER’s event curve continued to drop as LDL cholesterol fell below 10 mg/dL, the study’s wide-ranging safety assessment showed no signal of harm at the lowest levels. This “gives us some reassurance it’s safe,” he said in an interview. “We saw benefit that continued down to the lowest LDL levels, so it’s hard to pick a LDL target. I no longer feel comfortable treating my patients to just less than 70 mg/dL. I’m not sure what is the optimal LDL target, but I think it needs to be lower than that.”
To achieve such ultralow LDL levels, most patients need treatment with a PCSK9 inhibitor plus at least one and perhaps two additional cholesterol-lowering drugs, a statin and ezetimibe, he noted.
The FOURIER analyses Dr. Giugliano reported included data on the incidence during the study of 10 specific types of adverse events: noncardiovascular death, serious adverse events, adverse events leading to study discontinuation, and new onset of diabetes, cancer, cataract, neurocognitive deficit, significant liver enzyme increase, significant creatine kinase increase, and hemorrhagic stroke. The incidence of each of these was similar among the patients in five study subgroups based on achieved levels of LDL cholesterol: less than 20 mg/dL, 20-49 mg/dL, 50-69 mg/dL, 70-99 mg/dL, and 100 mg/dL or higher. In addition, the rates of both serious adverse events and adverse events leading to study discontinuation was roughly the same in the subgroup of patients with an achieved LDL cholesterol of less than 10 mg/dL as in those with an achieved LDL of at least 100 mg/dL.
Concurrently with Dr. Giugliano’s report, the results also appeared in an online article (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736[17]32290-0).
FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
[email protected]
On Twitter @mitchelzoler
BARCELONA – The maxim that lower is better for LDL cholesterol continues to hold true, even at jaw-droppingly low levels of less than 10 mg/dL in a new analysis of data from the FOURIER trial.
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial was the pivotal efficacy and safety study for the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab (Repatha) and enrolled patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of at least 70 mg/dL (N Engl J Med. 2017 May 4;376[18]:1713-22).
After a median follow-up of 26 months, the incidence of the study’s primary endpoint (cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization) dropped by a statistically significant 15% in patients with an achieved LDL cholesterol of 20-49 mg/dL, compared with patients whose 4-week LDL cholesterol was at or above 100 mg/dL (primarily patients randomized to the study’s control arm), by 24% in all patients with LDL cholesterol less than 20 mg/dL, and by 31% in the 2% of patients whose LDL cholesterol levels fell below 10 mg/dL.
These strikingly improved event rates at the lowest levels of LDL cholesterol occurred with no signal of excess adverse events, Robert P. Giugliano, MD, said at the annual congress of the European Society of Cardiology.
In contrast, the 13% of patents whose achieved LDL cholesterol was 50-69 mg/dL had an event rate just 6% below the referent group of 100 mg/dL or more, a nonsignificant difference. Existing cholesterol management guidelines that set LDL cholesterol targets for secondary prevention have used a level below 70 mg/dL as the target, such as the European Society of Cardiology’s 2016 guidelines (Eur Heart J. 2016 Oct 14;37[39]:2999-3058).
“The data suggest that we should target considerably lower LDL cholesterol than is currently recommended for our patients with atherosclerotic cardiovascular disease,” said Dr. Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston.
“Lowest is best with LDL. You don’t need a lot of LDL in the serum for normal human function,” he noted during the discussion of his report.
While FOURIER’s event curve continued to drop as LDL cholesterol fell below 10 mg/dL, the study’s wide-ranging safety assessment showed no signal of harm at the lowest levels. This “gives us some reassurance it’s safe,” he said in an interview. “We saw benefit that continued down to the lowest LDL levels, so it’s hard to pick a LDL target. I no longer feel comfortable treating my patients to just less than 70 mg/dL. I’m not sure what is the optimal LDL target, but I think it needs to be lower than that.”
To achieve such ultralow LDL levels, most patients need treatment with a PCSK9 inhibitor plus at least one and perhaps two additional cholesterol-lowering drugs, a statin and ezetimibe, he noted.
The FOURIER analyses Dr. Giugliano reported included data on the incidence during the study of 10 specific types of adverse events: noncardiovascular death, serious adverse events, adverse events leading to study discontinuation, and new onset of diabetes, cancer, cataract, neurocognitive deficit, significant liver enzyme increase, significant creatine kinase increase, and hemorrhagic stroke. The incidence of each of these was similar among the patients in five study subgroups based on achieved levels of LDL cholesterol: less than 20 mg/dL, 20-49 mg/dL, 50-69 mg/dL, 70-99 mg/dL, and 100 mg/dL or higher. In addition, the rates of both serious adverse events and adverse events leading to study discontinuation was roughly the same in the subgroup of patients with an achieved LDL cholesterol of less than 10 mg/dL as in those with an achieved LDL of at least 100 mg/dL.
Concurrently with Dr. Giugliano’s report, the results also appeared in an online article (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736[17]32290-0).
FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
[email protected]
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Patients with an achieved LDL of less than 10 mg/dL had an event rate 31% below patients with an LDL at or above 100 mg/dL.
Data source: FOURIER, an international multicenter trial with 27,564 patients.
Disclosures: FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). Dr. Giugliano has been a consultant to and has received research funding from Amgen, and he has also been a consultant to Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Pfizer.
Carpal tunnel syndrome may flag cardiac amyloidosis in elderly
DALLAS – Older patients with carpal tunnel syndrome that requires release surgery appear to have a relatively high prevalence of amyloidosis that, in some, involves their heart, suggesting that routine screening for amyloidosis is warranted in elderly patients undergoing the surgery.
Routine Congo red staining of a tenosynovial biopsy taken at the time of carpal tunnel release surgery in a single-center experience with 96 patients showed that 10 (10%) were positive for amyloidosis, Mazen Hanna, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Clinicians “should be aware of the association between carpal tunnel syndrome [CTS] and amyloidosis.” When a 60-year old shows up with bilateral CTS without a clear cause, it’s reasonable to suspect amyloidosis, he suggested.
The prospective study run by Dr. Hanna and his associates included men at least 50 years old and women at least 60 years old who underwent CTS release surgery at the Cleveland Clinic during May 2016–June 2017. Enrollment excluded patients with known amyloidosis or rheumatoid arthritis. The patients averaged 68 years of age, 51% were men, and 85% had bilateral CTS that required surgery. The surgeons removed a tenosynovial biopsy at the time of surgery from each of the 96 patients, a “low-risk procedure,” Dr. Hanna said.
The 10 patients with positive staining for amyloid underwent a work-up that included a comprehensive physical examination, a series of blood tests for cardiac biomarkers, an ECG, echocardiography including assessment of cardiac strain, and a technetium-99m pyrophosphate scan. This identified two patients with cardiac involvement. The examinations identified one case by the echocardiographic strain findings and the second case by the technetium pyrophosphate scan. Seven of the 10 patients with amyloid had a history of prior carpal tunnel release surgery.
The researchers also used mass spectroscopy to identify the amyloid type. Seven patients had the transthyretin subtype, including one patient with cardiac involvement; two patients had light chain amyloidosis, including the second patient with cardiac involvement. The tenth patient had inconclusive results but the researchers presumed the amyloid was of the transthyretin type, Dr. Hanna said.
The eight patients identified with amyloid but no cardiac involvement at baseline will continue to receive annual work ups to see whether their hearts become affected over time. The protocol delays a repeat technetium pyrophosphate scan until the 4th year following study entry.
The potential usefulness of early identification and treatment of cardiac amyloidosis received support in results from another study reported at the meeting. Researchers from Columbia University Medical Center, New York, and New York Presbyterian Hospital reported their retrospective, nonrandomized experience with 126 patients who had been diagnosed with transthyretin cardiac amyloidosis. Thirty of these patients had received treatment with a transthyretin-stabilizing drug, either the investigational agent tafamidis or diflunisal, while the other 96 patients received no stabilizing treatment. During a median follow-up of 2 years, patients treated with a stabilizing agent had a statistically significant 68% reduced rate of either death or orthotopic heart transplant, compared with the untreated patients in a multivariate analysis that controlled for various baseline differences between the treated and untreated patients.
[email protected]
On Twitter @mitchelzoler
DALLAS – Older patients with carpal tunnel syndrome that requires release surgery appear to have a relatively high prevalence of amyloidosis that, in some, involves their heart, suggesting that routine screening for amyloidosis is warranted in elderly patients undergoing the surgery.
Routine Congo red staining of a tenosynovial biopsy taken at the time of carpal tunnel release surgery in a single-center experience with 96 patients showed that 10 (10%) were positive for amyloidosis, Mazen Hanna, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Clinicians “should be aware of the association between carpal tunnel syndrome [CTS] and amyloidosis.” When a 60-year old shows up with bilateral CTS without a clear cause, it’s reasonable to suspect amyloidosis, he suggested.
The prospective study run by Dr. Hanna and his associates included men at least 50 years old and women at least 60 years old who underwent CTS release surgery at the Cleveland Clinic during May 2016–June 2017. Enrollment excluded patients with known amyloidosis or rheumatoid arthritis. The patients averaged 68 years of age, 51% were men, and 85% had bilateral CTS that required surgery. The surgeons removed a tenosynovial biopsy at the time of surgery from each of the 96 patients, a “low-risk procedure,” Dr. Hanna said.
The 10 patients with positive staining for amyloid underwent a work-up that included a comprehensive physical examination, a series of blood tests for cardiac biomarkers, an ECG, echocardiography including assessment of cardiac strain, and a technetium-99m pyrophosphate scan. This identified two patients with cardiac involvement. The examinations identified one case by the echocardiographic strain findings and the second case by the technetium pyrophosphate scan. Seven of the 10 patients with amyloid had a history of prior carpal tunnel release surgery.
The researchers also used mass spectroscopy to identify the amyloid type. Seven patients had the transthyretin subtype, including one patient with cardiac involvement; two patients had light chain amyloidosis, including the second patient with cardiac involvement. The tenth patient had inconclusive results but the researchers presumed the amyloid was of the transthyretin type, Dr. Hanna said.
The eight patients identified with amyloid but no cardiac involvement at baseline will continue to receive annual work ups to see whether their hearts become affected over time. The protocol delays a repeat technetium pyrophosphate scan until the 4th year following study entry.
The potential usefulness of early identification and treatment of cardiac amyloidosis received support in results from another study reported at the meeting. Researchers from Columbia University Medical Center, New York, and New York Presbyterian Hospital reported their retrospective, nonrandomized experience with 126 patients who had been diagnosed with transthyretin cardiac amyloidosis. Thirty of these patients had received treatment with a transthyretin-stabilizing drug, either the investigational agent tafamidis or diflunisal, while the other 96 patients received no stabilizing treatment. During a median follow-up of 2 years, patients treated with a stabilizing agent had a statistically significant 68% reduced rate of either death or orthotopic heart transplant, compared with the untreated patients in a multivariate analysis that controlled for various baseline differences between the treated and untreated patients.
[email protected]
On Twitter @mitchelzoler
DALLAS – Older patients with carpal tunnel syndrome that requires release surgery appear to have a relatively high prevalence of amyloidosis that, in some, involves their heart, suggesting that routine screening for amyloidosis is warranted in elderly patients undergoing the surgery.
Routine Congo red staining of a tenosynovial biopsy taken at the time of carpal tunnel release surgery in a single-center experience with 96 patients showed that 10 (10%) were positive for amyloidosis, Mazen Hanna, MD, said at the annual scientific meeting of the Heart Failure Society of America.
Clinicians “should be aware of the association between carpal tunnel syndrome [CTS] and amyloidosis.” When a 60-year old shows up with bilateral CTS without a clear cause, it’s reasonable to suspect amyloidosis, he suggested.
The prospective study run by Dr. Hanna and his associates included men at least 50 years old and women at least 60 years old who underwent CTS release surgery at the Cleveland Clinic during May 2016–June 2017. Enrollment excluded patients with known amyloidosis or rheumatoid arthritis. The patients averaged 68 years of age, 51% were men, and 85% had bilateral CTS that required surgery. The surgeons removed a tenosynovial biopsy at the time of surgery from each of the 96 patients, a “low-risk procedure,” Dr. Hanna said.
The 10 patients with positive staining for amyloid underwent a work-up that included a comprehensive physical examination, a series of blood tests for cardiac biomarkers, an ECG, echocardiography including assessment of cardiac strain, and a technetium-99m pyrophosphate scan. This identified two patients with cardiac involvement. The examinations identified one case by the echocardiographic strain findings and the second case by the technetium pyrophosphate scan. Seven of the 10 patients with amyloid had a history of prior carpal tunnel release surgery.
The researchers also used mass spectroscopy to identify the amyloid type. Seven patients had the transthyretin subtype, including one patient with cardiac involvement; two patients had light chain amyloidosis, including the second patient with cardiac involvement. The tenth patient had inconclusive results but the researchers presumed the amyloid was of the transthyretin type, Dr. Hanna said.
The eight patients identified with amyloid but no cardiac involvement at baseline will continue to receive annual work ups to see whether their hearts become affected over time. The protocol delays a repeat technetium pyrophosphate scan until the 4th year following study entry.
The potential usefulness of early identification and treatment of cardiac amyloidosis received support in results from another study reported at the meeting. Researchers from Columbia University Medical Center, New York, and New York Presbyterian Hospital reported their retrospective, nonrandomized experience with 126 patients who had been diagnosed with transthyretin cardiac amyloidosis. Thirty of these patients had received treatment with a transthyretin-stabilizing drug, either the investigational agent tafamidis or diflunisal, while the other 96 patients received no stabilizing treatment. During a median follow-up of 2 years, patients treated with a stabilizing agent had a statistically significant 68% reduced rate of either death or orthotopic heart transplant, compared with the untreated patients in a multivariate analysis that controlled for various baseline differences between the treated and untreated patients.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Ten of 96 patients undergoing carpal tunnel release surgery had amyloidosis, and two had cardiac involvement.
Data source: Prospective, single-center series of 96 patients undergoing carpal tunnel release surgery.
Disclosures: Dr. Hanna had no disclosures.
LVAD use soars in elderly Americans
DALLAS – The percentage of left ventricular assist devices placed in U.S. heart failure patients at least 75 years of age jumped sharply during 2003-2014, and concurrently the short-term survival of these patients improved dramatically, according to data collected by the National Inpatient Sample.
During the 12-year period examined, the percentage of left-ventricular assist devices (LVADs) placed in U.S. heart failure patients aged 75 years and older rose from 3% of all LVADs in 2003 to 11% in 2014, Aniket S. Rali, MD, said at the annual scientific meeting of the Heart Failure Society of America.
The U.S. national numbers also showed that throughout the period studied, elderly U.S. patients who received an LVAD were increasingly sicker, with steadily increasing numbers of patients with a Charlson Comorbidity Index score of four or greater. Despite this, in-hospital mortality rates of elderly patients receiving an LVAD plummeted, dropping from 61% of elderly LVAD recipients in 2003 to 18% in 2014. During the same time, the percentage of elderly patients with a Charlson Comorbidity Index score greater than four doubled from 33% in 2003 to 66% in 2014, said Dr. Rali, a cardiologist at the University of Kansas Medical Center in Kansas City.
“If the Charlson Comorbidity Index score is increasing but in-hospital mortality is decreasing, then increased LVAD use is not a bad trend,” Dr. Rali said in an interview. He hopes that future analysis of longitudinal data from patients could identify clinical factors that link with better patient survival and help target LVAD placement to the patients who stand to gain the most benefit.
“We may be able to give these elderly patients not just longer life but improved quality of life” by a more informed targeting of LVADs, he suggested. “I think these numbers will help convince people that all is not lost,” he noted, for elderly heart failure patients who receive an LVAD as destination therapy. Patients at least 75 years old are not eligible for heart transplantation, so when these patients receive an LVAD it is, by definition, destination therapy.
The data also showed a marked sex disparity in LVAD use, with LVAD placement in men at least 75 years old rising from 1.4/1,000 patients in 2003 to 2.78/1,000 patients in 2014. In contrast, among women these rates rose from 0.8/1,000 patients in 2003 to 1.36/1,000 patients in 2014.
The average age for elderly U.S. LVAD recipients for the entire 12-year period studied was 77.6 years among a total of 2,090 recipients. For all 21,323 U.S. LVAD recipients during 2003-2014 the average age was 51.5 years old.
[email protected]
On Twitter @mitchelzoler
DALLAS – The percentage of left ventricular assist devices placed in U.S. heart failure patients at least 75 years of age jumped sharply during 2003-2014, and concurrently the short-term survival of these patients improved dramatically, according to data collected by the National Inpatient Sample.
During the 12-year period examined, the percentage of left-ventricular assist devices (LVADs) placed in U.S. heart failure patients aged 75 years and older rose from 3% of all LVADs in 2003 to 11% in 2014, Aniket S. Rali, MD, said at the annual scientific meeting of the Heart Failure Society of America.
The U.S. national numbers also showed that throughout the period studied, elderly U.S. patients who received an LVAD were increasingly sicker, with steadily increasing numbers of patients with a Charlson Comorbidity Index score of four or greater. Despite this, in-hospital mortality rates of elderly patients receiving an LVAD plummeted, dropping from 61% of elderly LVAD recipients in 2003 to 18% in 2014. During the same time, the percentage of elderly patients with a Charlson Comorbidity Index score greater than four doubled from 33% in 2003 to 66% in 2014, said Dr. Rali, a cardiologist at the University of Kansas Medical Center in Kansas City.
“If the Charlson Comorbidity Index score is increasing but in-hospital mortality is decreasing, then increased LVAD use is not a bad trend,” Dr. Rali said in an interview. He hopes that future analysis of longitudinal data from patients could identify clinical factors that link with better patient survival and help target LVAD placement to the patients who stand to gain the most benefit.
“We may be able to give these elderly patients not just longer life but improved quality of life” by a more informed targeting of LVADs, he suggested. “I think these numbers will help convince people that all is not lost,” he noted, for elderly heart failure patients who receive an LVAD as destination therapy. Patients at least 75 years old are not eligible for heart transplantation, so when these patients receive an LVAD it is, by definition, destination therapy.
The data also showed a marked sex disparity in LVAD use, with LVAD placement in men at least 75 years old rising from 1.4/1,000 patients in 2003 to 2.78/1,000 patients in 2014. In contrast, among women these rates rose from 0.8/1,000 patients in 2003 to 1.36/1,000 patients in 2014.
The average age for elderly U.S. LVAD recipients for the entire 12-year period studied was 77.6 years among a total of 2,090 recipients. For all 21,323 U.S. LVAD recipients during 2003-2014 the average age was 51.5 years old.
[email protected]
On Twitter @mitchelzoler
DALLAS – The percentage of left ventricular assist devices placed in U.S. heart failure patients at least 75 years of age jumped sharply during 2003-2014, and concurrently the short-term survival of these patients improved dramatically, according to data collected by the National Inpatient Sample.
During the 12-year period examined, the percentage of left-ventricular assist devices (LVADs) placed in U.S. heart failure patients aged 75 years and older rose from 3% of all LVADs in 2003 to 11% in 2014, Aniket S. Rali, MD, said at the annual scientific meeting of the Heart Failure Society of America.
The U.S. national numbers also showed that throughout the period studied, elderly U.S. patients who received an LVAD were increasingly sicker, with steadily increasing numbers of patients with a Charlson Comorbidity Index score of four or greater. Despite this, in-hospital mortality rates of elderly patients receiving an LVAD plummeted, dropping from 61% of elderly LVAD recipients in 2003 to 18% in 2014. During the same time, the percentage of elderly patients with a Charlson Comorbidity Index score greater than four doubled from 33% in 2003 to 66% in 2014, said Dr. Rali, a cardiologist at the University of Kansas Medical Center in Kansas City.
“If the Charlson Comorbidity Index score is increasing but in-hospital mortality is decreasing, then increased LVAD use is not a bad trend,” Dr. Rali said in an interview. He hopes that future analysis of longitudinal data from patients could identify clinical factors that link with better patient survival and help target LVAD placement to the patients who stand to gain the most benefit.
“We may be able to give these elderly patients not just longer life but improved quality of life” by a more informed targeting of LVADs, he suggested. “I think these numbers will help convince people that all is not lost,” he noted, for elderly heart failure patients who receive an LVAD as destination therapy. Patients at least 75 years old are not eligible for heart transplantation, so when these patients receive an LVAD it is, by definition, destination therapy.
The data also showed a marked sex disparity in LVAD use, with LVAD placement in men at least 75 years old rising from 1.4/1,000 patients in 2003 to 2.78/1,000 patients in 2014. In contrast, among women these rates rose from 0.8/1,000 patients in 2003 to 1.36/1,000 patients in 2014.
The average age for elderly U.S. LVAD recipients for the entire 12-year period studied was 77.6 years among a total of 2,090 recipients. For all 21,323 U.S. LVAD recipients during 2003-2014 the average age was 51.5 years old.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Elderly U.S. patients receiving an LVAD rose from 3% of all LVADs placed in 2003 to 11% in 2014.
Data source: The U.S. National Inpatient Survey during 2003-2014.
Disclosures: Dr. Rali had no disclosures.
While U.S. heart failure readmissions fall, deaths rise
DALLAS – U.S. hospitals have recently shown a consistent and disturbing disconnect between reductions in their heart failure hospital readmission rates and heart failure mortality. Readmissions have dropped while mortality has risen.
“Despite reductions in 30-day heart failure readmissions in 89% of U.S. hospitals” during 2009-2016, “30-day heart failure mortality rates increased at 73%* of these ‘successful’ hospitals” during the same period,” Ahmad A. Abdul-Aziz, MD, said at the annual scientific meeting of the Heart Failure Society of America.
These shifts in the outcomes of U.S. patients hospitalized for acute heart failure episodes are tied to the penalties that the Centers for Medicare & Medicaid Services began slapping on hospitals in 2013 for excess 30-day readmissions for heart failure patients and in 2014 for excess mortality. A problem with these two CMS programs is that the penalty on inferior readmissions performance is a lot stiffer than for excess mortality, Dr. Aziz noted: a 0.2% penalty on payments for high mortality, compared with a 3% penalty for excess readmissions, a disparity that can make hospitals focus more on the readmissions side, he suggested.
Dr. Aziz’s report isn’t the first to make this observation. Study results published earlier in 2017 used CMS Medicare data from 2008 to 2014 to show that during that period, heart failure 30-day mortality rates following hospital discharge rose by 1.3%, while 30-day readmissions fell by 2.1% (JAMA. 2017 July 18;318[3]:270-8). On the basis of these numbers, as many as 5,200 additional deaths to U.S. heart failure patients in 2014 “may be related to the Hospital Readmission Reduction Program” of CMS, Gregg C. Fonarow, MD, said during a separate talk at the meeting.
The analysis reported by Dr. Aziz included data from 3,265 U.S. hospitals for heart failure patients, and data from 1,621 hospitals that managed patients with acute MIs, another disease that the CMS has targeted for penalties based on 30-day readmissions and 30-day postdischarge mortality rates. During the 8-year period studied, heart failure 30-day readmissions fell by 2.2% while 30-day mortality rose by 1%. In contrast, among acute MI patients, readmissions fell by 3% and mortality also fell, by 2.2%, Dr. Abdul-Aziz reported.
Dr. Abdul-Aziz had no disclosures. Dr. Fonarow had been a consultant to Amgen, Janssen, Medtronic, Novartis, St. Jude, and ZS Pharma.
[email protected]
On Twitter @mitchelzoler
*This article was updated October 5, 2017
My colleagues and I have seen in results from recent trials a changing relationship between heart failure mortality and heart failure hospitalization. In the United States in particular, where penalties exist for high rates of hospital readmissions for heart failure, we are seeing more patients treated as outpatients and we see that these “outpatient” events are associated with the same risk for subsequent mortality as we had previously seen for heart failure hospitalization.
It may be that we are keeping patients out of the hospital to avoid a financial ding, but perhaps we are keeping out patients who really should be hospitalized.
What we have begun doing in trials is to look not just at hospitalizations but also consider the incidence of other heart failure events, such as patients treated for heart failure symptoms with an intravenous diuretic in the emergency department and patients who are kept in observation rooms and are not admitted. It’s not the same as a heart failure hospitalization, but some trials are now including these other heart failure events in their primary endpoint.
Scott D. Solomon, MD, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital in Boston, made these comments as chair of the session where Dr. Aziz gave his report and in an interview. He has been a consultant to and/or received research support from Alnylam, Amgen, AstraZeneca, Bristol-Myers Squibb, Cytokinetics, GlaxoSmithKline, Ionis, Merck, Novartis, and Sanofi.
My colleagues and I have seen in results from recent trials a changing relationship between heart failure mortality and heart failure hospitalization. In the United States in particular, where penalties exist for high rates of hospital readmissions for heart failure, we are seeing more patients treated as outpatients and we see that these “outpatient” events are associated with the same risk for subsequent mortality as we had previously seen for heart failure hospitalization.
It may be that we are keeping patients out of the hospital to avoid a financial ding, but perhaps we are keeping out patients who really should be hospitalized.
What we have begun doing in trials is to look not just at hospitalizations but also consider the incidence of other heart failure events, such as patients treated for heart failure symptoms with an intravenous diuretic in the emergency department and patients who are kept in observation rooms and are not admitted. It’s not the same as a heart failure hospitalization, but some trials are now including these other heart failure events in their primary endpoint.
Scott D. Solomon, MD, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital in Boston, made these comments as chair of the session where Dr. Aziz gave his report and in an interview. He has been a consultant to and/or received research support from Alnylam, Amgen, AstraZeneca, Bristol-Myers Squibb, Cytokinetics, GlaxoSmithKline, Ionis, Merck, Novartis, and Sanofi.
My colleagues and I have seen in results from recent trials a changing relationship between heart failure mortality and heart failure hospitalization. In the United States in particular, where penalties exist for high rates of hospital readmissions for heart failure, we are seeing more patients treated as outpatients and we see that these “outpatient” events are associated with the same risk for subsequent mortality as we had previously seen for heart failure hospitalization.
It may be that we are keeping patients out of the hospital to avoid a financial ding, but perhaps we are keeping out patients who really should be hospitalized.
What we have begun doing in trials is to look not just at hospitalizations but also consider the incidence of other heart failure events, such as patients treated for heart failure symptoms with an intravenous diuretic in the emergency department and patients who are kept in observation rooms and are not admitted. It’s not the same as a heart failure hospitalization, but some trials are now including these other heart failure events in their primary endpoint.
Scott D. Solomon, MD, professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women’s Hospital in Boston, made these comments as chair of the session where Dr. Aziz gave his report and in an interview. He has been a consultant to and/or received research support from Alnylam, Amgen, AstraZeneca, Bristol-Myers Squibb, Cytokinetics, GlaxoSmithKline, Ionis, Merck, Novartis, and Sanofi.
DALLAS – U.S. hospitals have recently shown a consistent and disturbing disconnect between reductions in their heart failure hospital readmission rates and heart failure mortality. Readmissions have dropped while mortality has risen.
“Despite reductions in 30-day heart failure readmissions in 89% of U.S. hospitals” during 2009-2016, “30-day heart failure mortality rates increased at 73%* of these ‘successful’ hospitals” during the same period,” Ahmad A. Abdul-Aziz, MD, said at the annual scientific meeting of the Heart Failure Society of America.
These shifts in the outcomes of U.S. patients hospitalized for acute heart failure episodes are tied to the penalties that the Centers for Medicare & Medicaid Services began slapping on hospitals in 2013 for excess 30-day readmissions for heart failure patients and in 2014 for excess mortality. A problem with these two CMS programs is that the penalty on inferior readmissions performance is a lot stiffer than for excess mortality, Dr. Aziz noted: a 0.2% penalty on payments for high mortality, compared with a 3% penalty for excess readmissions, a disparity that can make hospitals focus more on the readmissions side, he suggested.
Dr. Aziz’s report isn’t the first to make this observation. Study results published earlier in 2017 used CMS Medicare data from 2008 to 2014 to show that during that period, heart failure 30-day mortality rates following hospital discharge rose by 1.3%, while 30-day readmissions fell by 2.1% (JAMA. 2017 July 18;318[3]:270-8). On the basis of these numbers, as many as 5,200 additional deaths to U.S. heart failure patients in 2014 “may be related to the Hospital Readmission Reduction Program” of CMS, Gregg C. Fonarow, MD, said during a separate talk at the meeting.
The analysis reported by Dr. Aziz included data from 3,265 U.S. hospitals for heart failure patients, and data from 1,621 hospitals that managed patients with acute MIs, another disease that the CMS has targeted for penalties based on 30-day readmissions and 30-day postdischarge mortality rates. During the 8-year period studied, heart failure 30-day readmissions fell by 2.2% while 30-day mortality rose by 1%. In contrast, among acute MI patients, readmissions fell by 3% and mortality also fell, by 2.2%, Dr. Abdul-Aziz reported.
Dr. Abdul-Aziz had no disclosures. Dr. Fonarow had been a consultant to Amgen, Janssen, Medtronic, Novartis, St. Jude, and ZS Pharma.
[email protected]
On Twitter @mitchelzoler
*This article was updated October 5, 2017
DALLAS – U.S. hospitals have recently shown a consistent and disturbing disconnect between reductions in their heart failure hospital readmission rates and heart failure mortality. Readmissions have dropped while mortality has risen.
“Despite reductions in 30-day heart failure readmissions in 89% of U.S. hospitals” during 2009-2016, “30-day heart failure mortality rates increased at 73%* of these ‘successful’ hospitals” during the same period,” Ahmad A. Abdul-Aziz, MD, said at the annual scientific meeting of the Heart Failure Society of America.
These shifts in the outcomes of U.S. patients hospitalized for acute heart failure episodes are tied to the penalties that the Centers for Medicare & Medicaid Services began slapping on hospitals in 2013 for excess 30-day readmissions for heart failure patients and in 2014 for excess mortality. A problem with these two CMS programs is that the penalty on inferior readmissions performance is a lot stiffer than for excess mortality, Dr. Aziz noted: a 0.2% penalty on payments for high mortality, compared with a 3% penalty for excess readmissions, a disparity that can make hospitals focus more on the readmissions side, he suggested.
Dr. Aziz’s report isn’t the first to make this observation. Study results published earlier in 2017 used CMS Medicare data from 2008 to 2014 to show that during that period, heart failure 30-day mortality rates following hospital discharge rose by 1.3%, while 30-day readmissions fell by 2.1% (JAMA. 2017 July 18;318[3]:270-8). On the basis of these numbers, as many as 5,200 additional deaths to U.S. heart failure patients in 2014 “may be related to the Hospital Readmission Reduction Program” of CMS, Gregg C. Fonarow, MD, said during a separate talk at the meeting.
The analysis reported by Dr. Aziz included data from 3,265 U.S. hospitals for heart failure patients, and data from 1,621 hospitals that managed patients with acute MIs, another disease that the CMS has targeted for penalties based on 30-day readmissions and 30-day postdischarge mortality rates. During the 8-year period studied, heart failure 30-day readmissions fell by 2.2% while 30-day mortality rose by 1%. In contrast, among acute MI patients, readmissions fell by 3% and mortality also fell, by 2.2%, Dr. Abdul-Aziz reported.
Dr. Abdul-Aziz had no disclosures. Dr. Fonarow had been a consultant to Amgen, Janssen, Medtronic, Novartis, St. Jude, and ZS Pharma.
[email protected]
On Twitter @mitchelzoler
*This article was updated October 5, 2017
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: From 2009 to 2016, U.S. 30-day heart failure readmissions fell by 2.2% while 30-day heart failure mortality rose by 1%.
Data source: Review of Medicare data for 3,265 U.S. hospitals managing heart failure patients.
Disclosures: Dr. Abdul-Aziz had no disclosures. Dr. Fonarow had been a consultant to Amgen, Janssen, Medtronic, Novartis, St. Jude, and ZS Pharma.
VIDEO: Educational intervention boosts A fib anticoagulation
BARCELONA – A program promoting broader anticoagulation of patients with atrial fibrillation that used education and feedback from practice audits produced a substantial increase in sustained anticoagulant use and cut strokes in a multinational study with almost 2,300 patients in 48 practices.
Among atrial fibrillation (AF) patients who were not on an anticoagulant at baseline (34% of the enrolled group) 48% of patients in the intervention group began anticoagulant treatment and remained on it for a year with intervention compared with 18% of patients in the control arm without the intervention, Christopher B. Granger, MD, said at the annual congress of the European Society of Cardiology.
The intervention, which highlighted to health care providers the opportunity to start their AF patients on anticoagulant treatment, “transforms how care is provided to this population” of AF patients, Dr. Granger said in a video interview. “Doing something like this can have enormous public health implications.”
IMPACT AF (The Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation) randomized 2,281 AF patients in 48 practices in five middle-income countries: Argentina, Brazil, China, India, and Romania. Randomization was by practice, and patients were assigned to either usual care or to an intervention that ran educational sessions for patients and providers on the benefits of and best practices for using anticoagulants. The intervention also monitored anticoagulant use by the patients in each practice and gave providers case-by-case feedback on the care patients received. The educational component customized the feedback to focus on overcoming treatment barriers specific for each patient. This audit and feedback process was a key part of the intervention, Dr. Granger said.
In an adjusted analysis, among patients not on an anticoagulant at baseline, the ones managed in practices that received the intervention had a greater than fourfold likelihood of receiving anticoagulant treatment, compared with patients in practices with no intervention. The intervention was especially successful in transitioning patients off of aspirin treatment, considered ineffective for AF stroke prevention, and onto an anticoagulant, most commonly warfarin.
Overall, anticoagulant use rose by 12 percentage points from baseline among patients in the intervention practices and by 3 percentage points over baseline among the control patients, a statistically significant difference for the study’s primary endpoint.
During 1-year follow-up, 11 strokes occurred among patients managed in practices that received the intervention and 21 in those in control practices, a 52% relative hazard reduction linked with the intervention that was statistically significant, Dr. Granger reported. Concurrently with his talk, the results also appeared online (Lancet. 2017. doi: 10.1016/S0140-6736[17]32165-7).
“How will we take what we have learned [in IMPACT AF] and have it available to people who want to replicate this?” asked Dr. Granger. “We have partnered with several national cardiology societies, and we are working with them to optimize the tools and provide the tools we’ve used,” he said. “We will develop a website for people who want to take this information and use it in their practices.” Dr. Granger and his associates also are working with the Food and Drug Administration and other groups to come up with interventions specially designed for U.S. practice.
IMPACT AF received partial funding from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Dr. Granger has received honoraria and research funding from all of these companies, and also from Janssen and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
IMPACT AF is an important study, with impressive results that confirm the value of integrated atrial fibrillation care. In the study, a comprehensive and continuous educational intervention with 11 distinct components aimed at health care professionals and patients increased the initiation of and adherence to oral anticoagulation in patients with AF. This effect linked with a significantly reduced incidence of strokes.
Digital tools are an important part of the intervention. They provide both information and feedback, and they create a platform that can involve all stakeholders in management of atrial fibrillation. Informing AF patients about their treatment can result in patients who take responsibility for their management. Integrated AF management models can improve continued delivery of chronic care.
Paulus Kirchhof, MD , is a professor and deputy director of the Institute of Cardiovascular Sciences at the University of Birmingham, England. He has received honoraria and research funding from several drug companies. He made these comments as designated discussant for the report.
IMPACT AF is an important study, with impressive results that confirm the value of integrated atrial fibrillation care. In the study, a comprehensive and continuous educational intervention with 11 distinct components aimed at health care professionals and patients increased the initiation of and adherence to oral anticoagulation in patients with AF. This effect linked with a significantly reduced incidence of strokes.
Digital tools are an important part of the intervention. They provide both information and feedback, and they create a platform that can involve all stakeholders in management of atrial fibrillation. Informing AF patients about their treatment can result in patients who take responsibility for their management. Integrated AF management models can improve continued delivery of chronic care.
Paulus Kirchhof, MD , is a professor and deputy director of the Institute of Cardiovascular Sciences at the University of Birmingham, England. He has received honoraria and research funding from several drug companies. He made these comments as designated discussant for the report.
IMPACT AF is an important study, with impressive results that confirm the value of integrated atrial fibrillation care. In the study, a comprehensive and continuous educational intervention with 11 distinct components aimed at health care professionals and patients increased the initiation of and adherence to oral anticoagulation in patients with AF. This effect linked with a significantly reduced incidence of strokes.
Digital tools are an important part of the intervention. They provide both information and feedback, and they create a platform that can involve all stakeholders in management of atrial fibrillation. Informing AF patients about their treatment can result in patients who take responsibility for their management. Integrated AF management models can improve continued delivery of chronic care.
Paulus Kirchhof, MD , is a professor and deputy director of the Institute of Cardiovascular Sciences at the University of Birmingham, England. He has received honoraria and research funding from several drug companies. He made these comments as designated discussant for the report.
BARCELONA – A program promoting broader anticoagulation of patients with atrial fibrillation that used education and feedback from practice audits produced a substantial increase in sustained anticoagulant use and cut strokes in a multinational study with almost 2,300 patients in 48 practices.
Among atrial fibrillation (AF) patients who were not on an anticoagulant at baseline (34% of the enrolled group) 48% of patients in the intervention group began anticoagulant treatment and remained on it for a year with intervention compared with 18% of patients in the control arm without the intervention, Christopher B. Granger, MD, said at the annual congress of the European Society of Cardiology.
The intervention, which highlighted to health care providers the opportunity to start their AF patients on anticoagulant treatment, “transforms how care is provided to this population” of AF patients, Dr. Granger said in a video interview. “Doing something like this can have enormous public health implications.”
IMPACT AF (The Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation) randomized 2,281 AF patients in 48 practices in five middle-income countries: Argentina, Brazil, China, India, and Romania. Randomization was by practice, and patients were assigned to either usual care or to an intervention that ran educational sessions for patients and providers on the benefits of and best practices for using anticoagulants. The intervention also monitored anticoagulant use by the patients in each practice and gave providers case-by-case feedback on the care patients received. The educational component customized the feedback to focus on overcoming treatment barriers specific for each patient. This audit and feedback process was a key part of the intervention, Dr. Granger said.
In an adjusted analysis, among patients not on an anticoagulant at baseline, the ones managed in practices that received the intervention had a greater than fourfold likelihood of receiving anticoagulant treatment, compared with patients in practices with no intervention. The intervention was especially successful in transitioning patients off of aspirin treatment, considered ineffective for AF stroke prevention, and onto an anticoagulant, most commonly warfarin.
Overall, anticoagulant use rose by 12 percentage points from baseline among patients in the intervention practices and by 3 percentage points over baseline among the control patients, a statistically significant difference for the study’s primary endpoint.
During 1-year follow-up, 11 strokes occurred among patients managed in practices that received the intervention and 21 in those in control practices, a 52% relative hazard reduction linked with the intervention that was statistically significant, Dr. Granger reported. Concurrently with his talk, the results also appeared online (Lancet. 2017. doi: 10.1016/S0140-6736[17]32165-7).
“How will we take what we have learned [in IMPACT AF] and have it available to people who want to replicate this?” asked Dr. Granger. “We have partnered with several national cardiology societies, and we are working with them to optimize the tools and provide the tools we’ve used,” he said. “We will develop a website for people who want to take this information and use it in their practices.” Dr. Granger and his associates also are working with the Food and Drug Administration and other groups to come up with interventions specially designed for U.S. practice.
IMPACT AF received partial funding from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Dr. Granger has received honoraria and research funding from all of these companies, and also from Janssen and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
BARCELONA – A program promoting broader anticoagulation of patients with atrial fibrillation that used education and feedback from practice audits produced a substantial increase in sustained anticoagulant use and cut strokes in a multinational study with almost 2,300 patients in 48 practices.
Among atrial fibrillation (AF) patients who were not on an anticoagulant at baseline (34% of the enrolled group) 48% of patients in the intervention group began anticoagulant treatment and remained on it for a year with intervention compared with 18% of patients in the control arm without the intervention, Christopher B. Granger, MD, said at the annual congress of the European Society of Cardiology.
The intervention, which highlighted to health care providers the opportunity to start their AF patients on anticoagulant treatment, “transforms how care is provided to this population” of AF patients, Dr. Granger said in a video interview. “Doing something like this can have enormous public health implications.”
IMPACT AF (The Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation) randomized 2,281 AF patients in 48 practices in five middle-income countries: Argentina, Brazil, China, India, and Romania. Randomization was by practice, and patients were assigned to either usual care or to an intervention that ran educational sessions for patients and providers on the benefits of and best practices for using anticoagulants. The intervention also monitored anticoagulant use by the patients in each practice and gave providers case-by-case feedback on the care patients received. The educational component customized the feedback to focus on overcoming treatment barriers specific for each patient. This audit and feedback process was a key part of the intervention, Dr. Granger said.
In an adjusted analysis, among patients not on an anticoagulant at baseline, the ones managed in practices that received the intervention had a greater than fourfold likelihood of receiving anticoagulant treatment, compared with patients in practices with no intervention. The intervention was especially successful in transitioning patients off of aspirin treatment, considered ineffective for AF stroke prevention, and onto an anticoagulant, most commonly warfarin.
Overall, anticoagulant use rose by 12 percentage points from baseline among patients in the intervention practices and by 3 percentage points over baseline among the control patients, a statistically significant difference for the study’s primary endpoint.
During 1-year follow-up, 11 strokes occurred among patients managed in practices that received the intervention and 21 in those in control practices, a 52% relative hazard reduction linked with the intervention that was statistically significant, Dr. Granger reported. Concurrently with his talk, the results also appeared online (Lancet. 2017. doi: 10.1016/S0140-6736[17]32165-7).
“How will we take what we have learned [in IMPACT AF] and have it available to people who want to replicate this?” asked Dr. Granger. “We have partnered with several national cardiology societies, and we are working with them to optimize the tools and provide the tools we’ve used,” he said. “We will develop a website for people who want to take this information and use it in their practices.” Dr. Granger and his associates also are working with the Food and Drug Administration and other groups to come up with interventions specially designed for U.S. practice.
IMPACT AF received partial funding from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Dr. Granger has received honoraria and research funding from all of these companies, and also from Janssen and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Anticoagulation rose by 12 percentage points from baseline with intervention and by 3 percentage points among controls.
Data source: IMPACT AF, which randomized 2,281 AF patients for 1 year at 48 centers in five middle-income countries.
Disclosures: IMPACT AF received partial funding from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Dr. Granger has received honoraria and research funding from all of these companies, and also from Janssen and Medtronic.
Calcitonin-to-CEA ratio predicts medullary thyroid cancer survival
BOSTON – The ratio of serum calcitonin to the serum level of carcinoembryonic antigen in patients with medullary thyroid cancer can predict which patients have a better chance for survival following thyroidectomy, based on retrospective findings from 164 presurgical patients at one U.S. center.
A lower serum calcitonin–to–serum carcinoembryonic antigen (CEA) ratio following thyroidectomy is a second marker of good postsurgical survival, Tania Jaber, MD, said at the World Congress on Thyroid Cancer.
“Patients want to know whether surgery will cure them, and we have had no prognostic markers to predict this. Depending on the ratio, we can now tell patients whether or not they have a good chance of cure,” said Dr. Jaber, an endocrinological oncologist at MD Anderson in Houston. “Surgery remains the standard of care, so the ratio does not affect the decision of whether to undergo surgery, but it helps patients know what to expect” after surgery, she said in an interview.
“If their ratio is favorable it can be reassuring, and if their ratio is unfavorable it helps set expectations. We are also studying whether the ratio can be a marker for the need for systemic therapy following surgery. Right now, our prognostic tools for medullary thyroid cancer are very limited, so any additional information we can give patients based on their calcitonin-to-CEA ratio is very valuable.”
Her study included 164 patients treated at MD Anderson who had their serum drawn before thyroidectomy, and 187 patients with specimens taken 3-9 months after surgery. Median patient follow-up after surgery was 5 years. Calcitonin levels were measured as pg/mL and CEA levels as ng/mL; despite this difference in unit size the researchers calculated the ratios by a direct numerical comparison that ignored the units.
Among the preoperative patients and specifically among those with a low serum CEA level of less than 25 ng/ML a calcitonin-to-CEA ratio of less than 43 had the best survival rate, Dr. Jaber reported. Among preoperative patients with a CEA level of 25 ng/mL or greater a ratio of less than 18 flagged patients with the best survival rate following thyroidectomy.
Among postoperative patients the ratios that linked with better survival also depended on the CEA level. In patients with a low postoperative CEA a ratio of less than 149 linked with better survival. In patients with a high CEA level a ratio of less than 12 linked with better postoperative survival.
[email protected]
On Twitter @mitchelzoler
BOSTON – The ratio of serum calcitonin to the serum level of carcinoembryonic antigen in patients with medullary thyroid cancer can predict which patients have a better chance for survival following thyroidectomy, based on retrospective findings from 164 presurgical patients at one U.S. center.
A lower serum calcitonin–to–serum carcinoembryonic antigen (CEA) ratio following thyroidectomy is a second marker of good postsurgical survival, Tania Jaber, MD, said at the World Congress on Thyroid Cancer.
“Patients want to know whether surgery will cure them, and we have had no prognostic markers to predict this. Depending on the ratio, we can now tell patients whether or not they have a good chance of cure,” said Dr. Jaber, an endocrinological oncologist at MD Anderson in Houston. “Surgery remains the standard of care, so the ratio does not affect the decision of whether to undergo surgery, but it helps patients know what to expect” after surgery, she said in an interview.
“If their ratio is favorable it can be reassuring, and if their ratio is unfavorable it helps set expectations. We are also studying whether the ratio can be a marker for the need for systemic therapy following surgery. Right now, our prognostic tools for medullary thyroid cancer are very limited, so any additional information we can give patients based on their calcitonin-to-CEA ratio is very valuable.”
Her study included 164 patients treated at MD Anderson who had their serum drawn before thyroidectomy, and 187 patients with specimens taken 3-9 months after surgery. Median patient follow-up after surgery was 5 years. Calcitonin levels were measured as pg/mL and CEA levels as ng/mL; despite this difference in unit size the researchers calculated the ratios by a direct numerical comparison that ignored the units.
Among the preoperative patients and specifically among those with a low serum CEA level of less than 25 ng/ML a calcitonin-to-CEA ratio of less than 43 had the best survival rate, Dr. Jaber reported. Among preoperative patients with a CEA level of 25 ng/mL or greater a ratio of less than 18 flagged patients with the best survival rate following thyroidectomy.
Among postoperative patients the ratios that linked with better survival also depended on the CEA level. In patients with a low postoperative CEA a ratio of less than 149 linked with better survival. In patients with a high CEA level a ratio of less than 12 linked with better postoperative survival.
[email protected]
On Twitter @mitchelzoler
BOSTON – The ratio of serum calcitonin to the serum level of carcinoembryonic antigen in patients with medullary thyroid cancer can predict which patients have a better chance for survival following thyroidectomy, based on retrospective findings from 164 presurgical patients at one U.S. center.
A lower serum calcitonin–to–serum carcinoembryonic antigen (CEA) ratio following thyroidectomy is a second marker of good postsurgical survival, Tania Jaber, MD, said at the World Congress on Thyroid Cancer.
“Patients want to know whether surgery will cure them, and we have had no prognostic markers to predict this. Depending on the ratio, we can now tell patients whether or not they have a good chance of cure,” said Dr. Jaber, an endocrinological oncologist at MD Anderson in Houston. “Surgery remains the standard of care, so the ratio does not affect the decision of whether to undergo surgery, but it helps patients know what to expect” after surgery, she said in an interview.
“If their ratio is favorable it can be reassuring, and if their ratio is unfavorable it helps set expectations. We are also studying whether the ratio can be a marker for the need for systemic therapy following surgery. Right now, our prognostic tools for medullary thyroid cancer are very limited, so any additional information we can give patients based on their calcitonin-to-CEA ratio is very valuable.”
Her study included 164 patients treated at MD Anderson who had their serum drawn before thyroidectomy, and 187 patients with specimens taken 3-9 months after surgery. Median patient follow-up after surgery was 5 years. Calcitonin levels were measured as pg/mL and CEA levels as ng/mL; despite this difference in unit size the researchers calculated the ratios by a direct numerical comparison that ignored the units.
Among the preoperative patients and specifically among those with a low serum CEA level of less than 25 ng/ML a calcitonin-to-CEA ratio of less than 43 had the best survival rate, Dr. Jaber reported. Among preoperative patients with a CEA level of 25 ng/mL or greater a ratio of less than 18 flagged patients with the best survival rate following thyroidectomy.
Among postoperative patients the ratios that linked with better survival also depended on the CEA level. In patients with a low postoperative CEA a ratio of less than 149 linked with better survival. In patients with a high CEA level a ratio of less than 12 linked with better postoperative survival.
[email protected]
On Twitter @mitchelzoler
AT WCTC 2017
Key clinical point:
Major finding: Presurgery, a calcitonin-to-CEA ratio below 18 was linked with superior survival in patients whose CEA was at least 25 ng/Ml.
Data source: A single-center, retrospective study with 164 patients assessed before thyroidectomy and 187 assessed after surgery.
Disclosures: Dr. Jaber had no disclosures.
Hepatitis C falls as barrier to heart transplantation
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
DALLAS – The heart transplant team at Vanderbilt University has successfully placed hearts from deceased, hepatitis C virus–positive patients into recipients, and then eradicated the subsequent infection that appeared in most recipients using a standard regimen.
So far, five of nine heart transplant recipients who developed a posttransplant hepatitis C virus (HCV) infection had the infection eradicated using one of the highly effective HCV drug regimens, and an additional three patients from the series are nearing their 12th week without detectable virus following treatment that marks a sustained response, Kelly H. Schlendorf, MD, said at the annual scientific meeting of the Heart Failure Society of America. The ninth patient died after developing a pulmonary embolism during the 7th week on antiviral therapy.
The recipients have been patients in a marginal clinical state and facing a long projected wait on the heart-recipient queue of the United Network for Organ Sharing (UNOS), Dr. Schlendorf said in an interview.
These have been “patients with a morbidity and mortality risk from waiting that can be mitigated by expanding the donor pool.” She gave an example of a patient with a left ventricular assist device that required replacement by either a second device or transplant, “so getting the transplant quickly was a good thing,” said Dr. Schlendorf, a cardiologist at Vanderbilt in Nashville.
Based on her analysis of UNOS data, “upwards of 100” and perhaps as many as 300 additional donor hearts could be available annually for U.S. transplants if the organs weren’t excluded because of HCV infection.
The Vanderbilt team has so far approached 15 patients in their program wait-listed for hearts about the possibility of accepting an HCV-positive organ, and all 15 have given their consent, she said. “We spend a lot of time talking with patients and their caregivers about the risks and benefits and possible complications.”
The 13 recipients, starting in September 2016, included 12 patients who were HCV naive and 1 patient with a history of HCV exposure. All 13 received the program’s standard three-drug regimen for immunosuppression.
During close surveillance, 9 of the 13 developed an infection. Patients with genotype 1 HCV received 12 weeks of treatment with ledipasvir plus sofosbuvir. Those infected with genotype 3 received 12-24 weeks of treatment with sofosbuvir plus velpatasvir. Treatment with these direct-acting antivirals meant that patients had to adjust the time when they took their proton-pump inhibitors, and they needed to stop treatment with diltiazem and statins while on the antivirals.
“In the era of direct-acting antivirals, HCV-positive donors may provide a safe and effective way to expand the donor pool and reduce wait-list times,” Dr. Schlendorf said. She noted that in recent years an increased number of potential organ donors have been HCV positive. She also cautioned that so far follow-up has been relatively brief, with no patient yet followed as long as 1 year after transplant.
The direct-acting HCV antivirals are expensive, and some payers established clinical criteria that patients must meet to qualify for coverage of these regimens. “We have not encountered difficulties getting insurers to pay,” Dr. Schlendorf said. Despite the antivirals’ cost there are significant cost savings from fewer days in the ICU waiting for heart transplantation and a reduced need for mechanical support as a bridge to transplant, she noted.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Eight of nine patients who developed HCV infection had it eradicated by a direct-acting antiviral regimen.
Data source: A series of 13 patients treated at one U.S. center.
Disclosures: Dr. Schlendorf had no disclosures.
Older men benefit from vascular screening
BARCELONA – Population screening for abdominal aortic aneurysms, peripheral arterial disease, and hypertension targeted to men aged 65-74 years saved lives in a highly cost-effective way in a Danish randomized study of more than 50,000 men.
During a median follow-up of 4.4 years, total mortality was 7% lower among men invited for this triple-screening panel, compared with uninvited controls – a statistically significant difference achieved without causing any identified serious adverse effects. The cost ran 2,148 euro (about $2,600) per quality adjusted year, making it very “cost attractive,” Jes S. Lindholt, DMSci, said at the annual congress of the European Society of Cardiology.
Dr. Lindholt also said that ongoing studies are assessing the clinical- and cost- effectiveness of screening for AAA and PAD in women in a targeted age range. But for the time being, “we believe the greatest benefit is in men.”
The Viborg Vascular (VIVA) screening trial (ClinicalTrials.gov NCT00662480) randomized all 50,156 men aged 65-74 years living in the central region of Denmark to either receive an invitation to triple disease screening or to receive no invitation and form the control group. Three-quarters of those invited for screening came to screening clinics at 14 regional centers. The examinations identified an AAA in 3%, PAD in 11%, and hypertension in 10%. About a third of people identified with AAA or PAD started treatment with aspirin, a statin, or both, and a small number of those with an AAA underwent surgical repair during the following 5 years. About a third of those newly diagnosed with hypertension began treatment with antihypertensive drugs.
The results showed that for every 169 men invited for screening the program saved one life during follow-up, compared with men in the control arm. “To our knowledge, no prior population-based screening program has shown an impact on overall mortality,” Dr. Lindholt said. Concurrently with his report, the results appeared online (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736(17)32250-X).
VIVA received no commercial funding. Dr. Lindholt had no disclosures.
[email protected]
On Twitter @mitchelzoler
Triple screening for abdominal aortic aneurysms, peripheral arterial disease, and hypertension is a good idea, and the new results from the VIVA trial serve as a call for broader screening initiatives.
Although the patients identified with one or more of the conditions screened received a relatively low rate of interventions, the program nonetheless produced a net benefit. The cost effectiveness of screening was very acceptable, and could potentially further improve if people identified with disease receive treatment sooner. The data showed a modest impact on quality of life, but the findings provided assurance that the screening program produced no excess adverse effects and no decrement in quality of life.
The study was also large and had a median follow-up of more than 4 years. The results also showed the risk for overdiagnosis was no worse than is seen with breast cancer screening.
Andrew M. Kates, MD , is a cardiologist and professor of medicine at Washington University in St. Louis. He had no disclosures. He made these comments as designated discussant for the VIVA trial.
Triple screening for abdominal aortic aneurysms, peripheral arterial disease, and hypertension is a good idea, and the new results from the VIVA trial serve as a call for broader screening initiatives.
Although the patients identified with one or more of the conditions screened received a relatively low rate of interventions, the program nonetheless produced a net benefit. The cost effectiveness of screening was very acceptable, and could potentially further improve if people identified with disease receive treatment sooner. The data showed a modest impact on quality of life, but the findings provided assurance that the screening program produced no excess adverse effects and no decrement in quality of life.
The study was also large and had a median follow-up of more than 4 years. The results also showed the risk for overdiagnosis was no worse than is seen with breast cancer screening.
Andrew M. Kates, MD , is a cardiologist and professor of medicine at Washington University in St. Louis. He had no disclosures. He made these comments as designated discussant for the VIVA trial.
Triple screening for abdominal aortic aneurysms, peripheral arterial disease, and hypertension is a good idea, and the new results from the VIVA trial serve as a call for broader screening initiatives.
Although the patients identified with one or more of the conditions screened received a relatively low rate of interventions, the program nonetheless produced a net benefit. The cost effectiveness of screening was very acceptable, and could potentially further improve if people identified with disease receive treatment sooner. The data showed a modest impact on quality of life, but the findings provided assurance that the screening program produced no excess adverse effects and no decrement in quality of life.
The study was also large and had a median follow-up of more than 4 years. The results also showed the risk for overdiagnosis was no worse than is seen with breast cancer screening.
Andrew M. Kates, MD , is a cardiologist and professor of medicine at Washington University in St. Louis. He had no disclosures. He made these comments as designated discussant for the VIVA trial.
BARCELONA – Population screening for abdominal aortic aneurysms, peripheral arterial disease, and hypertension targeted to men aged 65-74 years saved lives in a highly cost-effective way in a Danish randomized study of more than 50,000 men.
During a median follow-up of 4.4 years, total mortality was 7% lower among men invited for this triple-screening panel, compared with uninvited controls – a statistically significant difference achieved without causing any identified serious adverse effects. The cost ran 2,148 euro (about $2,600) per quality adjusted year, making it very “cost attractive,” Jes S. Lindholt, DMSci, said at the annual congress of the European Society of Cardiology.
Dr. Lindholt also said that ongoing studies are assessing the clinical- and cost- effectiveness of screening for AAA and PAD in women in a targeted age range. But for the time being, “we believe the greatest benefit is in men.”
The Viborg Vascular (VIVA) screening trial (ClinicalTrials.gov NCT00662480) randomized all 50,156 men aged 65-74 years living in the central region of Denmark to either receive an invitation to triple disease screening or to receive no invitation and form the control group. Three-quarters of those invited for screening came to screening clinics at 14 regional centers. The examinations identified an AAA in 3%, PAD in 11%, and hypertension in 10%. About a third of people identified with AAA or PAD started treatment with aspirin, a statin, or both, and a small number of those with an AAA underwent surgical repair during the following 5 years. About a third of those newly diagnosed with hypertension began treatment with antihypertensive drugs.
The results showed that for every 169 men invited for screening the program saved one life during follow-up, compared with men in the control arm. “To our knowledge, no prior population-based screening program has shown an impact on overall mortality,” Dr. Lindholt said. Concurrently with his report, the results appeared online (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736(17)32250-X).
VIVA received no commercial funding. Dr. Lindholt had no disclosures.
[email protected]
On Twitter @mitchelzoler
BARCELONA – Population screening for abdominal aortic aneurysms, peripheral arterial disease, and hypertension targeted to men aged 65-74 years saved lives in a highly cost-effective way in a Danish randomized study of more than 50,000 men.
During a median follow-up of 4.4 years, total mortality was 7% lower among men invited for this triple-screening panel, compared with uninvited controls – a statistically significant difference achieved without causing any identified serious adverse effects. The cost ran 2,148 euro (about $2,600) per quality adjusted year, making it very “cost attractive,” Jes S. Lindholt, DMSci, said at the annual congress of the European Society of Cardiology.
Dr. Lindholt also said that ongoing studies are assessing the clinical- and cost- effectiveness of screening for AAA and PAD in women in a targeted age range. But for the time being, “we believe the greatest benefit is in men.”
The Viborg Vascular (VIVA) screening trial (ClinicalTrials.gov NCT00662480) randomized all 50,156 men aged 65-74 years living in the central region of Denmark to either receive an invitation to triple disease screening or to receive no invitation and form the control group. Three-quarters of those invited for screening came to screening clinics at 14 regional centers. The examinations identified an AAA in 3%, PAD in 11%, and hypertension in 10%. About a third of people identified with AAA or PAD started treatment with aspirin, a statin, or both, and a small number of those with an AAA underwent surgical repair during the following 5 years. About a third of those newly diagnosed with hypertension began treatment with antihypertensive drugs.
The results showed that for every 169 men invited for screening the program saved one life during follow-up, compared with men in the control arm. “To our knowledge, no prior population-based screening program has shown an impact on overall mortality,” Dr. Lindholt said. Concurrently with his report, the results appeared online (Lancet. 2017 Aug 28. doi: 10.1016/S0140-6736(17)32250-X).
VIVA received no commercial funding. Dr. Lindholt had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Overall mortality during median follow-up of 4 years was 7% lower among men invited to screening, compared with unscreened controls.
Data source: VIVA, a randomized, multicenter trial of 50,156 Danish men.
Disclosures: VIVA received no commercial funding. Dr. Lindholt had no disclosures.